Obesity
Conditions
Keywords
frail elderly, telemedicine, obesity, rural health, health promotion, weight loss
Brief summary
The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.
Detailed description
The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity. Study Timeline: September 2017 to June 2018: Goal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session. Participation Duration: Three times weekly for 3 months
Interventions
The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.
Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).
The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.
The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.
Sponsors
Study design
Intervention model description
Two Arm Pilot Study
Eligibility
Inclusion criteria
All Aims: * Age ≥65 years * Body Mass Index (BMI) ≥ 30kg/m\^2 * Waist circumference ≥88cm in females or ≥102cm in males Aims 2 & 3: * Have Wi-Fi high speed internet * Able to obtain medical clearance from doctor * Have less than a 5% weight loss in past 6 months * No advanced co-morbidity * No exercise restrictions * Not involved in other research studies that may interfere with participation
Exclusion criteria
* Severe mental or life-threatening illness * Dementia * Substance use * History of bariatric surgery * Suicidal ideation * Unable to perform measures * Reside in nursing home * No advanced co-morbidity * No exercise restrictions * Not involved in other research studies that may interfere with participation Aim 4 - had to have completed Aims 2 or 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Grip Strength | Baseline, 12 weeks | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. |
| Change in Late-Life Function and Disability Instrument (LLFDI) | Baseline, 12 weeks | LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function. |
| Change in Gait Speed (m/s) | Baseline, 12 weeks | Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s). |
| Change in Six-Minute Walk Test (6MWT) | Baseline, 12 weeks | A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m |
| Change in 5 Times Sit-to-Stand (STS) | Baseline, 12 weeks | STS measures lower limb strength (minimal change 2.3 s). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy Expenditure | Baseline to 12 weeks | Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks |
| Change in Participant Satisfaction Questionnaire Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)) | The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention. |
| Change in Credibility and Expectancy Questionnaire Score | Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post | The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities | Change Score between baseline and 12 weeks | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Change Score between baseline and 12 weeks | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) | Change in KCal between baseline and 12 weeks | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - |
| Change in Insulin Level | Baseline, 12 weeks | insulin |
| Change in C-peptide | Baseline, 12 weeks | C-peptide |
| Change in C-reactive Protein | Baseline, 12 weeks | C-reactive protein |
| Change in Tumor Necrosis Factor Alpha | Baseline, 12 weeks | tumor necrosis factor alpha |
| Change in Interleukin 6 | Baseline, 12 weeks | Interleukin 6 |
| Change in Behavioral Activation (Patient Activation Measure) | Baseline, 12 weeks post study | Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation |
| Change in Subjective Health Status (PROMIS) Physical | Baseline, 12-weeks | Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health |
| Change in Weight in kg | Baseline, 12 weeks | Change in weight in kg |
| Change in Waist Circumference in cm | Baseline, 12 weeks post study | Change in waist and hip circumference in cm |
| Average Steps/Expenditure | Mean steps over 12 week period of time | Average Steps will be measured over a 12 week period |
| Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities | Change Score between baseline and 12 weeks | CHAMPS is a self-reported tool in older adults that assesses activity levels and types - |
| Change in Body Composition - Lean Mass | Baseline, 12 weeks | Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured |
| Change in Fasting Plasma Glucose | Baseline, 12 weeks | Fasting Plasma Glucose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | a 24-item assessment of external, introjected, identified, and intrinsic forms of regulation of exercise behavior. Higher scores indicated higher exercise behavior. each is scored on 5 points (0-120). Six subscales - each 4 items (score 0-20 each). A positive change score indicates higher forms of regulation. |
| Change in PROMIS Emotional Distress Short Form Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | an 8 item scale used to measure emotional distress/depression. higher score indicates higher distress. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent reduced emotional distress. |
| Change in PROMIS Social Isolation Short Form Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | An 8-item scale used to measure perceived social isolation.higher scores indicate higher isolation. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent high isolation. |
| Change in Three Factor Eating Questionnaire Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | 18-item scale measuring eating behavior with 3 subscales (cognitive restraint, emotional eating, uncontrolled eating) using Likert scale (1-4 point scale). Items 1-16 on this scale are reverse scored. The scale score is then entered into the following formula: (cognitive restraint scale score - 3)/9. The outcome is then multiplied by 100. Higher scores indicate higher restraint, emotional eating or uncontrolled eating, respectively. Subscales aretransformed to 0-100 score To calculate the emotional eating sub scale, reverse scored items 2, 4, 7, 10, 14 and 16 are summed and then averaged to generate a mean score. The mean score is then multiplied by 6 to generate a scale score. The scale score is then entered into the following formula: (emotional eating scale score - 6)/18. The outcome is then multiplied by 100. Positive change scores represent lower restraint, higher emotional eating or higher uncontrolled eating. |
| Change in Discomfort Intolerance Scale Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | The Discomfort intolerance Scale is a 6-item questionnaire which measures general difficulty managing and regulating physical distress and discomfort using a Likert scale (1-6 point scale: not at all like me = 1 to very much like me = 6). Total scores range 6-36: higher scores indicate greater distress intolerance. |
| Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken | Baseline, 12 weeks post study | Medication adherence, visual analog scale |
| Change in Food Craving Acceptance and Action Questionnaire Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | The Food Craving Acceptance and Action Questionnaire is a 10-item questionnaire which measures acceptance of food related cravings and urges using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of food related cravings and urges. |
| Change in Voluntary Exercise Questionnaire Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | The Voluntary Exercise Questionnaire is a brief 6-item questionnaire which measures participants' participation in aerobic and strength training activities over the past 3 months and past week. Two items use a Likert scale (1-7 point scale: never = 1 to 7 = very often) and four items ask participants to report frequency of exercise: 0 = 0 days per week to 7 = 7 days per week). Total score range 2-42: Higher scores indicate greater levels of aerobic and strength training activity. |
| Change in Weight Control Strategies Scale Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | The Weight Control Strategies Scale is a 30-item questionnaire which measures participants' use of behavioral weight control strategies using a Likert scale (1-4 point scale: never = 0 to always = 4). Total scores range 0-120: higher scores indicate greater use of weight control strategies. |
| Change in Physical Activity Acceptance & Action Questionnaire Score | Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI) | The Physical Activity Acceptance & Action Questionnaire is a 10-item scale which measures acceptance of physical and psychological discomfort in the context of physical activity using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of physical and psychological discomfort in the context of physical activity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Develop & Refine MOWI w/o Amulet (2A) Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.
Develop & Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks. | 9 |
| MOWI Weight Loss Maintenance Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.
MOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification). | 27 |
| Develop & Refine MOWI w Fitbit (2B) Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.
Develop & Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. | 16 |
| Develop & Refine MOWI w Fitbit/Protein (2P) Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.
Develop & Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions. | 16 |
| Total | 68 |
Baseline characteristics
| Characteristic | Develop & Refine MOWI w/o Amulet (2A) | Total | Develop & Refine MOWI w Fitbit/Protein (2P) | Develop & Refine MOWI w Fitbit (2B) | MOWI Weight Loss Maintenance |
|---|---|---|---|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 5.1 | 72.5 years STANDARD_DEVIATION 5.3 | 72.9 years STANDARD_DEVIATION 4.4 | 73.0 years STANDARD_DEVIATION 6.3 | 72.7 years STANDARD_DEVIATION 4.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 68 Participants | 16 Participants | 16 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 68 Participants | 16 Participants | 16 Participants | 27 Participants |
| Region of Enrollment United States | 9 participants | 60 participants | 14 participants | 14 participants | 23 participants |
| Sex: Female, Male Female | 6 Participants | 56 Participants | 14 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 3 Participants | 12 Participants | 2 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 23 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 4 / 9 | 0 / 23 | 12 / 14 | 5 / 14 |
| serious Total, serious adverse events | 1 / 9 | 0 / 23 | 3 / 14 | 1 / 14 |
Outcome results
Change in 5 Times Sit-to-Stand (STS)
STS measures lower limb strength (minimal change 2.3 s).
Time frame: Baseline, 12 weeks
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in 5 Times Sit-to-Stand (STS) | -2.9 Seconds | Standard Deviation 2.9 |
| Develop & Refine MOWI w Fitbit (2B) | Change in 5 Times Sit-to-Stand (STS) | -1.5 Seconds | Standard Deviation 1.7 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in 5 Times Sit-to-Stand (STS) | -2.6 Seconds | Standard Deviation 2.2 |
Change in Gait Speed (m/s)
Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).
Time frame: Baseline, 12 weeks
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Gait Speed (m/s) | 0.2 M/s | Standard Deviation 0.1 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Gait Speed (m/s) | 0.1 M/s | Standard Deviation 0.1 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Gait Speed (m/s) | 0.1 M/s | Standard Deviation 0.1 |
Change in Grip Strength
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.
Time frame: Baseline, 12 weeks
Population: For MOWI Weight Loss Maintenance, this was not a measure of evaluation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Grip Strength | 6.2 Kg | Standard Deviation 5.1 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Grip Strength | -2.6 Kg | Standard Deviation 5.2 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Grip Strength | 4.3 Kg | Standard Deviation 3.4 |
Change in Late-Life Function and Disability Instrument (LLFDI)
LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.
Time frame: Baseline, 12 weeks
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Late-Life Function and Disability Instrument (LLFDI) | 8.6 Points | Standard Deviation 8.6 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Late-Life Function and Disability Instrument (LLFDI) | 9.0 Points | Standard Deviation 8.6 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Late-Life Function and Disability Instrument (LLFDI) | 6.3 Points | Standard Deviation 6.9 |
Change in Six-Minute Walk Test (6MWT)
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Time frame: Baseline, 12 weeks
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Six-Minute Walk Test (6MWT) | 47.5 Meters | Standard Deviation 83 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Six-Minute Walk Test (6MWT) | 39.3 Meters | Standard Deviation 51.6 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Six-Minute Walk Test (6MWT) | 31.8 Meters | Standard Deviation 27.8 |
Average Steps/Expenditure
Average Steps will be measured over a 12 week period
Time frame: Mean steps over 12 week period of time
Population: For MOWI Weight Loss Maintenance this was not evaluated. For Aim 2A, no fitness device was provided to participants and hence cannot evaluate this outcome in that arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Average Steps/Expenditure | 6494 Steps | Standard Deviation 3700 |
| Develop & Refine MOWI w Fitbit (2B) | Average Steps/Expenditure | 5127 Steps | Standard Deviation 3467 |
Change in Behavioral Activation (Patient Activation Measure)
Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation
Time frame: Baseline, 12 weeks post study
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioral Activation (Patient Activation Measure) | 9.2 Points | Standard Deviation 11.3 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Behavioral Activation (Patient Activation Measure) | 18.8 Points | Standard Deviation 14.5 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Behavioral Activation (Patient Activation Measure) | 11.0 Points | Standard Deviation 10.8 |
Change in Body Composition - Lean Mass
Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured
Time frame: Baseline, 12 weeks
Population: For MOWI Weight Loss Maintenance this was not evaluated. In 2A (Develop \& Refine MOWI w/o Amulet was not measured. This technique was not available for MOWI 2A participants and hence not measured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Body Composition - Lean Mass | -0.62 Kg | Standard Deviation 1.4 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Body Composition - Lean Mass | -1.44 Kg | Standard Deviation 1.45 |
Change in C-peptide
C-peptide
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in C-peptide | -0.02 ng/mL | Standard Deviation 0.67 |
| Develop & Refine MOWI w Fitbit (2B) | Change in C-peptide | 0.69 ng/mL | Standard Deviation 1.25 |
Change in C-reactive Protein
C-reactive protein
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in C-reactive Protein | -2.00 mg/L | Standard Deviation 3.96 |
| Develop & Refine MOWI w Fitbit (2B) | Change in C-reactive Protein | -0.65 mg/L | Standard Deviation 1.86 |
Change in Credibility and Expectancy Questionnaire Score
The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention
Time frame: Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post
Population: only measured in this intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Credibility and Expectancy Questionnaire Score | -0.623529 score on a scale | Standard Deviation 2.776583 |
Change in Energy Expenditure
Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Energy Expenditure | -251.6 kCal | Standard Deviation 579.9 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Energy Expenditure | -206.8 kCal | Standard Deviation 608 |
Change in Fasting Plasma Glucose
Fasting Plasma Glucose
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Fasting Plasma Glucose | -12.2 mg/mL | Standard Deviation 25.8 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Fasting Plasma Glucose | -4 mg/mL | Standard Deviation 13.9 |
Change in Insulin Level
insulin
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Insulin Level | -7.8 mIU/L | Standard Deviation 10.1 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Insulin Level | -1.32 mIU/L | Standard Deviation 4.68 |
Change in Interleukin 6
Interleukin 6
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Interleukin 6 | 0.10 pg/mL | Standard Deviation 2.14 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Interleukin 6 | -0.44 pg/mL | Standard Deviation 1.26 |
Change in Participant Satisfaction Questionnaire Score
The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI))
Population: only measured in maintenance arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Participant Satisfaction Questionnaire Score | 3.13 score on a scale | Standard Deviation 0.773 |
Change in Subjective Health Status (PROMIS) Physical
Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health
Time frame: Baseline, 12-weeks
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Subjective Health Status (PROMIS) Physical | 3.0 Points | Standard Deviation 4.4 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Subjective Health Status (PROMIS) Physical | 6.4 Points | Standard Deviation 5.3 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Subjective Health Status (PROMIS) Physical | 2.3 Points | Standard Deviation 3.6 |
Change in Tumor Necrosis Factor Alpha
tumor necrosis factor alpha
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Tumor Necrosis Factor Alpha | -0.19 pg/mL | Standard Deviation 0.23 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Tumor Necrosis Factor Alpha | -0.08 pg/mL | Standard Deviation 0.28 |
Change in Waist Circumference in cm
Change in waist and hip circumference in cm
Time frame: Baseline, 12 weeks post study
Population: For MOWI Weight Loss Maintenance this was not evaluated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Waist Circumference in cm | -7.6 Cm | Standard Deviation 4.9 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Waist Circumference in cm | -6.4 Cm | Standard Deviation 6.3 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Waist Circumference in cm | -14.8 Cm | Standard Deviation 45.5 |
Change in Weight in kg
Change in weight in kg
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Weight in kg | -4.3 Kg | Standard Deviation 3.2 |
| Develop & Refine MOWI w Fitbit (2B) | Change in Weight in kg | -3.5238 Kg | Standard Deviation 9.11762 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Weight in kg | -5.8 Kg | Standard Deviation 3.1 |
| Develop & Refine MOWI w Fitbit/Protein (2P) | Change in Weight in kg | -3.5 Kg | Standard Deviation 2.9 |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)
CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Time frame: Change in KCal between baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) | Low intensity caloric expenditure per week | 5.3 kCal | Standard Deviation 29.5 |
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) | Moderate intensity caloric expenditure | 49.4 kCal | Standard Deviation 74.9 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) | Low intensity caloric expenditure per week | 5.7 kCal | Standard Deviation 19.2 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) | Moderate intensity caloric expenditure | 13.8 kCal | Standard Deviation 44.3 |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration
CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Time frame: Change Score between baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Not exercising activity duration per week | -2.2 hours | Standard Deviation 9.7 |
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Low intensity activity duration | 1.7 hours | Standard Deviation 7.7 |
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Moderate intensity activity duration | 7.3 hours | Standard Deviation 9.6 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Not exercising activity duration per week | -2.0 hours | Standard Deviation 9 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Low intensity activity duration | 1.8 hours | Standard Deviation 4.9 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration | Moderate intensity activity duration | 2.4 hours | Standard Deviation 7.2 |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities
CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Time frame: Change Score between baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities | Low intensity activities per week | 3.9 activities per week | Standard Deviation 6.9 |
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities | Moderate intensity activities per week | 8.6 activities per week | Standard Deviation 9.2 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities | Low intensity activities per week | 4.5 activities per week | Standard Deviation 6.9 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities | Moderate intensity activities per week | 5.2 activities per week | Standard Deviation 9.1 |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities
CHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Time frame: Change Score between baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities | -3.1 activities per week | Standard Deviation 11.4 |
| Develop & Refine MOWI w Fitbit (2B) | Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities | -5.4 activities per week | Standard Deviation 11.6 |
Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score
a 24-item assessment of external, introjected, identified, and intrinsic forms of regulation of exercise behavior. Higher scores indicated higher exercise behavior. each is scored on 5 points (0-120). Six subscales - each 4 items (score 0-20 each). A positive change score indicates higher forms of regulation.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only assessed in this arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | Amotivation subscale | -0.1324 units on a scale | Standard Deviation 0.5312 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | External regulation subscale | -0.3088 units on a scale | Standard Deviation 0.7317 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | Introjected regulation subscale | -0.6618 units on a scale | Standard Deviation 1.01912 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | Identified regulation subscale | -0.0588 units on a scale | Standard Deviation 0.38047 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | Integrated regulation subscale | 0.2794 units on a scale | Standard Deviation 0.72824 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score | Intrisic motivation subscale | -0.0294 units on a scale | Standard Deviation 0.64881 |
Change in Discomfort Intolerance Scale Score
The Discomfort intolerance Scale is a 6-item questionnaire which measures general difficulty managing and regulating physical distress and discomfort using a Likert scale (1-6 point scale: not at all like me = 1 to very much like me = 6). Total scores range 6-36: higher scores indicate greater distress intolerance.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only measured in this arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Discomfort Intolerance Scale Score | -1.2941 score on a scale | Standard Deviation 4.63364 |
Change in Food Craving Acceptance and Action Questionnaire Score
The Food Craving Acceptance and Action Questionnaire is a 10-item questionnaire which measures acceptance of food related cravings and urges using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of food related cravings and urges.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only measured in this arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Food Craving Acceptance and Action Questionnaire Score | -1.058824 score on a scale | Standard Deviation 6.832556 |
Change in Physical Activity Acceptance & Action Questionnaire Score
The Physical Activity Acceptance & Action Questionnaire is a 10-item scale which measures acceptance of physical and psychological discomfort in the context of physical activity using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of physical and psychological discomfort in the context of physical activity.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only measured in this arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Physical Activity Acceptance & Action Questionnaire Score | 3.2941 score on a scale | Standard Deviation 8.54228 |
Change in PROMIS Emotional Distress Short Form Score
an 8 item scale used to measure emotional distress/depression. higher score indicates higher distress. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent reduced emotional distress.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: Only assessed in this arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in PROMIS Emotional Distress Short Form Score | 2.8824 units on a scale | Standard Deviation 5.20675 |
Change in PROMIS Social Isolation Short Form Score
An 8-item scale used to measure perceived social isolation.higher scores indicate higher isolation. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent high isolation.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only assessed in this arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in PROMIS Social Isolation Short Form Score | -1.5294 units on a scale | Standard Deviation 4.30287 |
Change in Three Factor Eating Questionnaire Score
18-item scale measuring eating behavior with 3 subscales (cognitive restraint, emotional eating, uncontrolled eating) using Likert scale (1-4 point scale). Items 1-16 on this scale are reverse scored. The scale score is then entered into the following formula: (cognitive restraint scale score - 3)/9. The outcome is then multiplied by 100. Higher scores indicate higher restraint, emotional eating or uncontrolled eating, respectively. Subscales aretransformed to 0-100 score To calculate the emotional eating sub scale, reverse scored items 2, 4, 7, 10, 14 and 16 are summed and then averaged to generate a mean score. The mean score is then multiplied by 6 to generate a scale score. The scale score is then entered into the following formula: (emotional eating scale score - 6)/18. The outcome is then multiplied by 100. Positive change scores represent lower restraint, higher emotional eating or higher uncontrolled eating.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only assessed in this arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Three Factor Eating Questionnaire Score | Uncontrolled eating subscale | -0.823 units on a scale | Standard Deviation 14.17778 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Three Factor Eating Questionnaire Score | Cognitive restraint subscale | 3.0864 units on a scale | Standard Deviation 18.19987 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Three Factor Eating Questionnaire Score | Emotional eating subscale | 0.6173 units on a scale | Standard Deviation 20.68971 |
Change in Voluntary Exercise Questionnaire Score
The Voluntary Exercise Questionnaire is a brief 6-item questionnaire which measures participants' participation in aerobic and strength training activities over the past 3 months and past week. Two items use a Likert scale (1-7 point scale: never = 1 to 7 = very often) and four items ask participants to report frequency of exercise: 0 = 0 days per week to 7 = 7 days per week). Total score range 2-42: Higher scores indicate greater levels of aerobic and strength training activity.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: only assessed in this arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Voluntary Exercise Questionnaire Score | Aerobic | -3.1111 score on a scale | Standard Deviation 4.523 |
| Develop & Refine MOWI w/o Amulet (2A) | Change in Voluntary Exercise Questionnaire Score | Strength | 0.2222 score on a scale | Standard Deviation 3.42234 |
Change in Weight Control Strategies Scale Score
The Weight Control Strategies Scale is a 30-item questionnaire which measures participants' use of behavioral weight control strategies using a Likert scale (1-4 point scale: never = 0 to always = 4). Total scores range 0-120: higher scores indicate greater use of weight control strategies.
Time frame: Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)
Population: assessed only in this arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Change in Weight Control Strategies Scale Score | 0.1241 score on a scale | Standard Deviation 0.7082 |
Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken
Medication adherence, visual analog scale
Time frame: Baseline, 12 weeks post study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Develop & Refine MOWI w/o Amulet (2A) | Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken | 82.6 percentage of total sessions |