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MOWI Research Pilot

Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03104192
Enrollment
69
Registered
2017-04-07
Start date
2017-09-01
Completion date
2020-01-11
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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

BEHAVIORALDevelop & 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.

BEHAVIORALMOWI 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).

BEHAVIORALDevelop & 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.

DIETARY_SUPPLEMENTDevelop & 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Two Arm Pilot Study

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in Grip StrengthBaseline, 12 weeksAssessed 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 weeksLLFDI 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 weeksGait 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 weeksA 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 weeksSTS measures lower limb strength (minimal change 2.3 s).

Secondary

MeasureTime frameDescription
Change in Energy ExpenditureBaseline to 12 weeksResting metabolic rate, Change Score (kCal) from Baseline to 12 weeks
Change in Participant Satisfaction Questionnaire ScoreChange 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 ScoreBaseline (of maintenance intervention) and 6 months (into maintenance) - pre/postThe 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 ActivitiesChange Score between baseline and 12 weeksCHAMPS 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 DurationChange Score between baseline and 12 weeksCHAMPS 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 weeksCHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Change in Insulin LevelBaseline, 12 weeksinsulin
Change in C-peptideBaseline, 12 weeksC-peptide
Change in C-reactive ProteinBaseline, 12 weeksC-reactive protein
Change in Tumor Necrosis Factor AlphaBaseline, 12 weekstumor necrosis factor alpha
Change in Interleukin 6Baseline, 12 weeksInterleukin 6
Change in Behavioral Activation (Patient Activation Measure)Baseline, 12 weeks post studyPatient 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) PhysicalBaseline, 12-weeksPatient 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 kgBaseline, 12 weeksChange in weight in kg
Change in Waist Circumference in cmBaseline, 12 weeks post studyChange in waist and hip circumference in cm
Average Steps/ExpenditureMean steps over 12 week period of timeAverage Steps will be measured over a 12 week period
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of ActivitiesChange Score between baseline and 12 weeksCHAMPS is a self-reported tool in older adults that assesses activity levels and types -
Change in Body Composition - Lean MassBaseline, 12 weeksLean 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 GlucoseBaseline, 12 weeksFasting Plasma Glucose

Other

MeasureTime frameDescription
Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreChange 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 ScoreChange 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 ScoreChange 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 ScoreChange 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 ScoreChange 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 TakenBaseline, 12 weeks post studyMedication adherence, visual analog scale
Change in Food Craving Acceptance and Action Questionnaire ScoreChange 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 ScoreChange 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 ScoreChange 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 ScoreChange 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

ArmCount
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
Total68

Baseline characteristics

CharacteristicDevelop & Refine MOWI w/o Amulet (2A)TotalDevelop & Refine MOWI w Fitbit/Protein (2P)Develop & Refine MOWI w Fitbit (2B)MOWI Weight Loss Maintenance
Age, Continuous71.0 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 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants68 Participants16 Participants16 Participants27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants68 Participants16 Participants16 Participants27 Participants
Region of Enrollment
United States
9 participants60 participants14 participants14 participants23 participants
Sex: Female, Male
Female
6 Participants56 Participants14 Participants12 Participants24 Participants
Sex: Female, Male
Male
3 Participants12 Participants2 Participants4 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 230 / 140 / 14
other
Total, other adverse events
4 / 90 / 2312 / 145 / 14
serious
Total, serious adverse events
1 / 90 / 233 / 141 / 14

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in 5 Times Sit-to-Stand (STS)-2.9 SecondsStandard Deviation 2.9
Develop & Refine MOWI w Fitbit (2B)Change in 5 Times Sit-to-Stand (STS)-1.5 SecondsStandard Deviation 1.7
Develop & Refine MOWI w Fitbit/Protein (2P)Change in 5 Times Sit-to-Stand (STS)-2.6 SecondsStandard Deviation 2.2
Primary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Gait Speed (m/s)0.2 M/sStandard Deviation 0.1
Develop & Refine MOWI w Fitbit (2B)Change in Gait Speed (m/s)0.1 M/sStandard Deviation 0.1
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Gait Speed (m/s)0.1 M/sStandard Deviation 0.1
Primary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Grip Strength6.2 KgStandard Deviation 5.1
Develop & Refine MOWI w Fitbit (2B)Change in Grip Strength-2.6 KgStandard Deviation 5.2
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Grip Strength4.3 KgStandard Deviation 3.4
Primary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Late-Life Function and Disability Instrument (LLFDI)8.6 PointsStandard Deviation 8.6
Develop & Refine MOWI w Fitbit (2B)Change in Late-Life Function and Disability Instrument (LLFDI)9.0 PointsStandard Deviation 8.6
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Late-Life Function and Disability Instrument (LLFDI)6.3 PointsStandard Deviation 6.9
Primary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Six-Minute Walk Test (6MWT)47.5 MetersStandard Deviation 83
Develop & Refine MOWI w Fitbit (2B)Change in Six-Minute Walk Test (6MWT)39.3 MetersStandard Deviation 51.6
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Six-Minute Walk Test (6MWT)31.8 MetersStandard Deviation 27.8
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Average Steps/Expenditure6494 StepsStandard Deviation 3700
Develop & Refine MOWI w Fitbit (2B)Average Steps/Expenditure5127 StepsStandard Deviation 3467
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioral Activation (Patient Activation Measure)9.2 PointsStandard Deviation 11.3
Develop & Refine MOWI w Fitbit (2B)Change in Behavioral Activation (Patient Activation Measure)18.8 PointsStandard Deviation 14.5
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Behavioral Activation (Patient Activation Measure)11.0 PointsStandard Deviation 10.8
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Body Composition - Lean Mass-0.62 KgStandard Deviation 1.4
Develop & Refine MOWI w Fitbit (2B)Change in Body Composition - Lean Mass-1.44 KgStandard Deviation 1.45
Secondary

Change in C-peptide

C-peptide

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in C-peptide-0.02 ng/mLStandard Deviation 0.67
Develop & Refine MOWI w Fitbit (2B)Change in C-peptide0.69 ng/mLStandard Deviation 1.25
Secondary

Change in C-reactive Protein

C-reactive protein

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in C-reactive Protein-2.00 mg/LStandard Deviation 3.96
Develop & Refine MOWI w Fitbit (2B)Change in C-reactive Protein-0.65 mg/LStandard Deviation 1.86
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Credibility and Expectancy Questionnaire Score-0.623529 score on a scaleStandard Deviation 2.776583
Secondary

Change in Energy Expenditure

Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks

Time frame: Baseline to 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Energy Expenditure-251.6 kCalStandard Deviation 579.9
Develop & Refine MOWI w Fitbit (2B)Change in Energy Expenditure-206.8 kCalStandard Deviation 608
Secondary

Change in Fasting Plasma Glucose

Fasting Plasma Glucose

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Fasting Plasma Glucose-12.2 mg/mLStandard Deviation 25.8
Develop & Refine MOWI w Fitbit (2B)Change in Fasting Plasma Glucose-4 mg/mLStandard Deviation 13.9
Secondary

Change in Insulin Level

insulin

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Insulin Level-7.8 mIU/LStandard Deviation 10.1
Develop & Refine MOWI w Fitbit (2B)Change in Insulin Level-1.32 mIU/LStandard Deviation 4.68
Secondary

Change in Interleukin 6

Interleukin 6

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Interleukin 60.10 pg/mLStandard Deviation 2.14
Develop & Refine MOWI w Fitbit (2B)Change in Interleukin 6-0.44 pg/mLStandard Deviation 1.26
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Participant Satisfaction Questionnaire Score3.13 score on a scaleStandard Deviation 0.773
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Subjective Health Status (PROMIS) Physical3.0 PointsStandard Deviation 4.4
Develop & Refine MOWI w Fitbit (2B)Change in Subjective Health Status (PROMIS) Physical6.4 PointsStandard Deviation 5.3
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Subjective Health Status (PROMIS) Physical2.3 PointsStandard Deviation 3.6
Secondary

Change in Tumor Necrosis Factor Alpha

tumor necrosis factor alpha

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Tumor Necrosis Factor Alpha-0.19 pg/mLStandard Deviation 0.23
Develop & Refine MOWI w Fitbit (2B)Change in Tumor Necrosis Factor Alpha-0.08 pg/mLStandard Deviation 0.28
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Waist Circumference in cm-7.6 CmStandard Deviation 4.9
Develop & Refine MOWI w Fitbit (2B)Change in Waist Circumference in cm-6.4 CmStandard Deviation 6.3
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Waist Circumference in cm-14.8 CmStandard Deviation 45.5
Secondary

Change in Weight in kg

Change in weight in kg

Time frame: Baseline, 12 weeks

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Weight in kg-4.3 KgStandard Deviation 3.2
Develop & Refine MOWI w Fitbit (2B)Change in Weight in kg-3.5238 KgStandard Deviation 9.11762
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Weight in kg-5.8 KgStandard Deviation 3.1
Develop & Refine MOWI w Fitbit/Protein (2P)Change in Weight in kg-3.5 KgStandard Deviation 2.9
Secondary

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

ArmMeasureGroupValue (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 week5.3 kCalStandard Deviation 29.5
Develop & Refine MOWI w/o Amulet (2A)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)Moderate intensity caloric expenditure49.4 kCalStandard 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 week5.7 kCalStandard Deviation 19.2
Develop & Refine MOWI w Fitbit (2B)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)Moderate intensity caloric expenditure13.8 kCalStandard Deviation 44.3
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in DurationNot exercising activity duration per week-2.2 hoursStandard Deviation 9.7
Develop & Refine MOWI w/o Amulet (2A)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in DurationLow intensity activity duration1.7 hoursStandard Deviation 7.7
Develop & Refine MOWI w/o Amulet (2A)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in DurationModerate intensity activity duration7.3 hoursStandard Deviation 9.6
Develop & Refine MOWI w Fitbit (2B)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in DurationNot exercising activity duration per week-2.0 hoursStandard Deviation 9
Develop & Refine MOWI w Fitbit (2B)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in DurationLow intensity activity duration1.8 hoursStandard Deviation 4.9
Develop & Refine MOWI w Fitbit (2B)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in DurationModerate intensity activity duration2.4 hoursStandard Deviation 7.2
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of ActivitiesLow intensity activities per week3.9 activities per weekStandard 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 ActivitiesModerate intensity activities per week8.6 activities per weekStandard Deviation 9.2
Develop & Refine MOWI w Fitbit (2B)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of ActivitiesLow intensity activities per week4.5 activities per weekStandard Deviation 6.9
Develop & Refine MOWI w Fitbit (2B)Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of ActivitiesModerate intensity activities per week5.2 activities per weekStandard Deviation 9.1
Secondary

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

ArmMeasureValue (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 weekStandard 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 weekStandard Deviation 11.6
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreAmotivation subscale-0.1324 units on a scaleStandard Deviation 0.5312
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreExternal regulation subscale-0.3088 units on a scaleStandard Deviation 0.7317
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreIntrojected regulation subscale-0.6618 units on a scaleStandard Deviation 1.01912
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreIdentified regulation subscale-0.0588 units on a scaleStandard Deviation 0.38047
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreIntegrated regulation subscale0.2794 units on a scaleStandard Deviation 0.72824
Develop & Refine MOWI w/o Amulet (2A)Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) ScoreIntrisic motivation subscale-0.0294 units on a scaleStandard Deviation 0.64881
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Discomfort Intolerance Scale Score-1.2941 score on a scaleStandard Deviation 4.63364
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Food Craving Acceptance and Action Questionnaire Score-1.058824 score on a scaleStandard Deviation 6.832556
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Physical Activity Acceptance & Action Questionnaire Score3.2941 score on a scaleStandard Deviation 8.54228
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in PROMIS Emotional Distress Short Form Score2.8824 units on a scaleStandard Deviation 5.20675
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in PROMIS Social Isolation Short Form Score-1.5294 units on a scaleStandard Deviation 4.30287
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Three Factor Eating Questionnaire ScoreUncontrolled eating subscale-0.823 units on a scaleStandard Deviation 14.17778
Develop & Refine MOWI w/o Amulet (2A)Change in Three Factor Eating Questionnaire ScoreCognitive restraint subscale3.0864 units on a scaleStandard Deviation 18.19987
Develop & Refine MOWI w/o Amulet (2A)Change in Three Factor Eating Questionnaire ScoreEmotional eating subscale0.6173 units on a scaleStandard Deviation 20.68971
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Voluntary Exercise Questionnaire ScoreAerobic-3.1111 score on a scaleStandard Deviation 4.523
Develop & Refine MOWI w/o Amulet (2A)Change in Voluntary Exercise Questionnaire ScoreStrength0.2222 score on a scaleStandard Deviation 3.42234
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Develop & Refine MOWI w/o Amulet (2A)Change in Weight Control Strategies Scale Score0.1241 score on a scaleStandard Deviation 0.7082
Other Pre-specified

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

ArmMeasureValue (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 Taken82.6 percentage of total sessions

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026