Physical Disability
Conditions
Keywords
Weight Loss, Physical Activity, Diet
Brief summary
The objective of this study is to compare weight loss (6 mos.) and maintenance (18 mos.) between an individual home visit intervention (IH) and an intervention delivered remotely via video conferencing to groups of overweight/obese adults with Mobility Related Disabilities (MRDs) in their homes (GR). The primary aim will be to compare weight loss (0-6 mos.) between the two interventions (IH vs. GR). Secondarily, the study team will compare the mean weight loss from 0-18 mos., the proportion of participants achieving \>=5% weight loss from baseline, changes in cardiovascular risk factors and quality of life, and conduct a cost analysis. In addition, factors that will be explored include the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), Physical Activity (PA, min of moderate vigorous PA, min sedentary time), and self-monitoring of diet and PA, self-efficacy for dietary change and PA, dietary self-regulation, social support for diet/PA, barriers to PA, sleep and medications on weight loss at 6 and 18 mos.
Detailed description
The investigators propose a 2-arm randomized trial (group remote (GR) vs. individual home visit (IH)) using intent-to-treat principles, to compare body weight following weight loss (6 mos.) and maintenance (18 mos.) in overweight/obese adults with Mobility Related Disabilities (MRDs). Adults with MRDs (n=128) will be randomized (1:1) to one of the 2 intervention arms for an 18-mo. trial (6 mos. weight loss, 12 mos. maintenance). Cohorts of \ 30-45 individuals will be recruited. Following baseline testing, participants will be stratified by their primary mode of locomotion outside the home, i.e., ambulatory or assistive device (wheelchair, scooter, etc.), and randomized with equal allocation to GR or IH arms. Both interventions will be delivered in a format that eliminates the transportation barrier, prescribed an enhanced stop light diet, and will self-monitor body weight using electronic scales. The GR arm will include group behavioral counseling and group PA delivered remotely via video conferencing (Zoom trademark software) on a tablet computer (iPad mini) to participants in their homes, and use commercially available web-based applications for self-monitoring/participant feedback for diet (Lose It! software) and PA (Fitbit activity tracker). The IH arm will include behavioral counseling delivered during individual home visits, a prescription for self-directed PA, and self-monitoring of diet and PA using conventional paper and pencil self-reports. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary aim will be to compare weight loss (0-6 mos.) between the GR and IH interventions. Secondarily, the research team will compare mean weight loss from 0-18 mos., the proportion of participants achieving \>=5% weight loss from baseline, changes in cardiovascular risk factors and quality of life, and conduct a cost analysis. In addition, the influence of behavioral session attendance, compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), PA (min of moderate-vigorous PA, min sedentary time), and self-monitoring of diet and PA, self-efficacy for dietary change and PA, dietary self-regulation, social support for diet/PA, barriers to PA, sleep, and medications on weight loss between the IH and GR arms will be explored, with 80% power and a type 1 error rate of 0.05, assuming a common standard deviation of 6 kg, will require 64 participants/group. A 2-sample independent t-test will be used to compare 6 mo. weight loss (primary aim) between the 2 intervention arms in both an intent-to-treat and completer only analysis. For the secondary aim 1, comparison of 18 mo. weight loss, will mirror the analysis for the primary aim. A 2-sample t-test will be used to compare weight change (0-18 mos.) between the 2 intervention arms. For secondary aim 2, a between arm comparison of the proportion of participants achieving \>=5% weight loss (0-18 mos.) will be evaluated using a chi-square test. Secondary aims 3 and 4, between arm comparison of change in risk factors and quality of life (0-6 and 0-18 mos.), will be evaluated using a 2-sample ttest. Exploratory aims will examine the influence of the following on weight loss at 6 mos.: behavioral session attendance; compliance with the recommendations for diet (energy intake, number of entrees/shakes, servings of fruits/vegetables), PA (min of moderate-vigorous PA, min sedentary time), self-monitoring of diet and PA, sleep, and medications assessed over the time period of interest i.e. (0-6 and 0-18 mos.); and the changes in self-efficacy for PA and dietary change, dietary self-regulation, social support for diet/PA, and barriers to PA from 0-6 mos. The influence of these factors as covariates will be examined, in addition to treatment, on weight loss at 6 mos. This will allow the ability to identify which variables most highly influence the outcome along with treatment and/or the mechanism(s) of action that are impacting weight loss.
Interventions
DIETARY_SUPPLEMENTenhanced Stop Light Diet
Stop light diet enhanced with portion-controlled meals
BEHAVIORALGroup Remote
Participants will receive remotely delivered weight loss in a group setting.
BEHAVIORALIndividual In-Person
Participants will receive a weight loss intervention during individual, at-home visits.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A permanent MRD (\>= 1 yr. duration) requiring the use of a wheelchair or resulting in the inability to walk 0.25 miles without stopping, with or without assistive devices, as documented by 7 items from the NHANES Physical Funding Survey (113), and confirmed by the Primary Care Physician (PCP). Individuals with MRDs, associated with, but not limited to spinal cord injury (SCI), spina bifida, multiple sclerosis, cerebral palsy, stroke, muscular dystrophy, and lower limb amputation will be included. * Age 18 yrs and above. Weight management for younger individuals requires different behavioral strategies. * Body mass index (BMI) above 25 kg/m squared. Individuals with BMI, with a BMI \<25kg/m squared are not overweight. We are aware of the difficulty in the assessment of BMI, and issues related to the use of BMI for classifying overweight/obesity in individuals with SCI or amputations. Thus, in questionable cases we will defer to the PCP regarding eligibility based on weight status. * Wireless internet access in the home.
Exclusion criteria
* Unable to participate in light-to-moderate intensity PA, e.g., seated aerobics, resistance exercise, or physically unable to use the iPad. * Participation in a structured weight loss or exercise program in the previous 6 mos. These proximal exercises may influence this trial. * Not weight stable (plus/minus 4.6 kg) for 3 mos. prior to intake. * Unwilling to be randomized. * Pregnancy during the previous 6 mos. currently lactating, or planned pregnancy in the following 18 mos. * Serious medical risk, e.g., cancer, recent heart attack, stroke as determined by the PCP. * Current use of antipsychotics, untreated depression, or other psychiatric illness that would preclude participation in weight management, as determined by the PCP. Psychiatric co-morbidity may limit the benefits from health education. Addressing psychiatric issues is beyond the scope of this study. * Cognitive, visual, or hearing impairments that may interfere with compliance to the study protocol as determined by the PCP. * Adherence to specialized diets, e.g., food allergies, vegetarian, macrobiotic. * Binge (Binge Eating Scale) or other eating disorders (EATs-26).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change in kg From Baseline to 6-months | Baseline and 6 months | Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Intervention | Across 18 months | The cost of both the IH and GR interventions will be calculated along with the cost per additional kg of weight loss. |
| Weight | Baseline, 6, 12, and 18 months | Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight. |
| Waist Circumference | Baseline, 6, 12, and 18 months | Measured in cm around narrowest part of the waist. |
| Blood Pressure | Baseline, 6, 12, and 18 months | Obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol. |
| Change in Quality of Life | Baseline, 6, 12, and 18 months | Assessed with the SF-36E. The SF-36E measures quality of life on a 0-100 scale with 0 being low quality and 100 being high quality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Barriers to Exercise | Baseline, 6, 12, and 18 months | Assessed using the Barriers to Exercise for Disabled Person. Individuals are asked a question relating to a specific exercise barrier and if it has limited their participation in the past three months. If they answer yes, they are asked to rate the limitation of that barrier on a scale of 1 to 5 with 1 being the least and 5 being the most limiting. Scores are calculated using weighted sums of the items. |
| Diet Self-regulation | Baseline, 6, 12, and 18 months | Assessed using the Three-Factor Eating Inventory, a widely-used measure of eating behavior (restraint, disinhibition, hunger). Participant is asked a question and to rate how they feel on a 1-4 scale with 1 being definitely false and 4 being definitely true. |
| Social Support | Baseline, 6, 12, and 18 months | Social support for both exercise and dietary habits will be assessed using the Social Support and Exercise/Diet Survey. This survey utilizes questions focusing on support by peers and family members that participants answer using a 1-5 rating with 1 being no support and 5 being very supportive. |
| Sleep | Baseline, 6, 12, and 18 months | Sleep Quality will be assessed using The Pittsburgh Sleep Quality Index. Participants answer open-ended questions as well as questions on a 0-3 scale. Seven component scores are tallied using provided measures, and a global sum of 5or greater on all seven components indicates a poor sleeper. |
| Medication Information | Baseline, 6, 12, and 18 months | Medication name/frequency/amount will be collected by participant self-report |
| Energy Expenditure | 3-12 months | Energy expenditure of the remote sessions will be assessed in a volunteer sample using a previously validated portable, open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-breath ventilation, expired oxygen, and carbon dioxide. |
| Compliance With the Diet Recommendations | Baseline, 6, 12, and 18 months | Will be assessed using photo-assisted food records over 4 consecutive days (3 wk. days and 1 wk. end day) starting the weekend prior to scheduled outcome assessments. |
| Compliance With Physical Activity Recommendations | Baseline, 6, 12, and 18 months | Assessed using the Physical Activity and Disability Survey (PADS). The PADS is a semi-structured interview that includes subscales for exercise, leisure time PA, household activity, and inactivity (sleeping, TV, computer use). |
| Behavioral Session Attendance | Across 18 months | Expressed as the percentage of possible sessions attended |
| Self-monitoring of Diet/PA | Across 18 months | The percentage of prescribed monitoring days completed across 18 mos. |
| Self-efficacy for Dietary Change | Baseline, 6, 12, and 18 months | Assessed using the Weight Efficacy Lifestyle Scale. This scale has participants rate a question from 1 to 10 with 1 being Not at all confident and 10 being Very confident. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individual In-Person enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals
Individual In-Person: Participants will receive a weight loss intervention during individual, at-home visits. | 63 |
| Group Remote enhanced Stop Light Diet: Stop light diet enhanced with portion-controlled meals
Group Remote: Participants will receive remotely delivered weight loss in a group setting. | 66 |
| Total | 129 |
Baseline characteristics
| Characteristic | Individual In-Person | Group Remote | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 24 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 42 Participants | 90 Participants |
| Age, Continuous | 54.3 years STANDARD_DEVIATION 12.4 | 55.9 years STANDARD_DEVIATION 14.3 | 55.1 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 58 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 45 Participants | 55 Participants | 100 Participants |
| Region of Enrollment United States | 63 participants | 66 participants | 129 participants |
| Sex: Female, Male Female | 50 Participants | 53 Participants | 103 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 66 |
| other Total, other adverse events | 0 / 63 | 0 / 66 |
| serious Total, serious adverse events | 4 / 63 | 2 / 66 |
Outcome results
Primary
Weight Change in kg From Baseline to 6-months
Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual In-Person | Weight Change in kg From Baseline to 6-months | -6.23 kg | Standard Deviation 6.7 |
| Group Remote | Weight Change in kg From Baseline to 6-months | -8.16 kg | Standard Deviation 6.74 |
Secondary
Blood Pressure
Obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol.
Time frame: Baseline, 6, 12, and 18 months
Secondary
Change in Quality of Life
Assessed with the SF-36E. The SF-36E measures quality of life on a 0-100 scale with 0 being low quality and 100 being high quality.
Time frame: Baseline, 6, 12, and 18 months
Secondary
Cost of Intervention
The cost of both the IH and GR interventions will be calculated along with the cost per additional kg of weight loss.
Time frame: Across 18 months
Secondary
Waist Circumference
Measured in cm around narrowest part of the waist.
Time frame: Baseline, 6, 12, and 18 months
Secondary
Weight
Weight will be measured in duplicate with a portable, calibrated digital scale. (Model #PS6600, Befour, Saukville, WI.). For those in a wheelchair, weight will be measured in duplicate using a portable calibrated, digital wheelchair scale (Model MX420, Befour, Saukville, WI.). Participant weight will be calculated as participant + chair weight minus chair weight.
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Barriers to Exercise
Assessed using the Barriers to Exercise for Disabled Person. Individuals are asked a question relating to a specific exercise barrier and if it has limited their participation in the past three months. If they answer yes, they are asked to rate the limitation of that barrier on a scale of 1 to 5 with 1 being the least and 5 being the most limiting. Scores are calculated using weighted sums of the items.
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Behavioral Session Attendance
Expressed as the percentage of possible sessions attended
Time frame: Across 18 months
Other Pre-specified
Compliance With Physical Activity Recommendations
Assessed using the Physical Activity and Disability Survey (PADS). The PADS is a semi-structured interview that includes subscales for exercise, leisure time PA, household activity, and inactivity (sleeping, TV, computer use).
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Compliance With the Diet Recommendations
Will be assessed using photo-assisted food records over 4 consecutive days (3 wk. days and 1 wk. end day) starting the weekend prior to scheduled outcome assessments.
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Diet Self-regulation
Assessed using the Three-Factor Eating Inventory, a widely-used measure of eating behavior (restraint, disinhibition, hunger). Participant is asked a question and to rate how they feel on a 1-4 scale with 1 being definitely false and 4 being definitely true.
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Energy Expenditure
Energy expenditure of the remote sessions will be assessed in a volunteer sample using a previously validated portable, open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-breath ventilation, expired oxygen, and carbon dioxide.
Time frame: 3-12 months
Other Pre-specified
Medication Information
Medication name/frequency/amount will be collected by participant self-report
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Self-efficacy for Dietary Change
Assessed using the Weight Efficacy Lifestyle Scale. This scale has participants rate a question from 1 to 10 with 1 being Not at all confident and 10 being Very confident.
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Self-monitoring of Diet/PA
The percentage of prescribed monitoring days completed across 18 mos.
Time frame: Across 18 months
Other Pre-specified
Sleep
Sleep Quality will be assessed using The Pittsburgh Sleep Quality Index. Participants answer open-ended questions as well as questions on a 0-3 scale. Seven component scores are tallied using provided measures, and a global sum of 5or greater on all seven components indicates a poor sleeper.
Time frame: Baseline, 6, 12, and 18 months
Other Pre-specified
Social Support
Social support for both exercise and dietary habits will be assessed using the Social Support and Exercise/Diet Survey. This survey utilizes questions focusing on support by peers and family members that participants answer using a 1-5 rating with 1 being no support and 5 being very supportive.
Time frame: Baseline, 6, 12, and 18 months