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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK116669-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual In-Person | Other |
| |
| Group Remote | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enhanced Stop Light Diet | Dietary Supplement | Stop light diet enhanced with portion-controlled meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6, 12, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6, 12, and 18 months |
| Compliance With Physical Activity Recommendations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Donnelly, EdD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32768682 | Derived | Washburn RA, Ptomey LT, Gorczyca AM, Smith PR, Mayo MS, Lee R, Donnelly JE. Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial. Contemp Clin Trials. 2020 Sep;96:106098. doi: 10.1016/j.cct.2020.106098. Epub 2020 Aug 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-month |
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| 12-month |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Group Remote |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | kg | Baseline and 6 months |
|
Baseline to 6-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Donnelly | University of Kansas Medical Center | 785-864-1687 | jdonnelly2@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2024 | Jun 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Group Remote | Behavioral | Participants will receive remotely delivered weight loss in a group setting. |
|
| Individual In-Person | Behavioral | Participants will receive a weight loss intervention during individual, at-home visits. |
|
| Waist Circumference | Measured in cm around narrowest part of the waist. | Baseline, 6, 12, and 18 months |
| Blood Pressure | Obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol. | Baseline, 6, 12, and 18 months |
| 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. | Baseline, 6, 12, and 18 months |
| 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. | Across 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). |
| Baseline, 6, 12, and 18 months |
| Behavioral Session Attendance | Expressed as the percentage of possible sessions attended | Across 18 months |
| Self-monitoring of Diet/PA | The percentage of prescribed monitoring days completed across 18 mos. | Across 18 months |
| 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." | Baseline, 6, 12, and 18 months |
| 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. | Baseline, 6, 12, and 18 months |
| 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." | Baseline, 6, 12, and 18 months |
| 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." | Baseline, 6, 12, and 18 months |
| 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 "5"or greater on all seven components indicates a "poor" sleeper. | Baseline, 6, 12, and 18 months |
| Medication Information | Medication name/frequency/amount will be collected by participant self-report | Baseline, 6, 12, and 18 months |
| 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. | 3-12 months |
| NOT COMPLETED |
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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.
|
|
| 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. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| Secondary | Waist Circumference | Measured in cm around narrowest part of the waist. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| Secondary | Blood Pressure | Obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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. | Not Posted | Across 18 months | Participants |
| 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. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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). | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| Other Pre-specified | Behavioral Session Attendance | Expressed as the percentage of possible sessions attended | Not Posted | Across 18 months | Participants |
| Other Pre-specified | Self-monitoring of Diet/PA | The percentage of prescribed monitoring days completed across 18 mos. | Not Posted | Across 18 months | Participants |
| 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." | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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." | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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." | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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 "5"or greater on all seven components indicates a "poor" sleeper. | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| Other Pre-specified | Medication Information | Medication name/frequency/amount will be collected by participant self-report | Not Posted | Baseline, 6, 12, and 18 months | Participants |
| 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. | Not Posted | 3-12 months | Participants |
| 0 |
| 63 |
| 4 |
| 63 |
| 0 |
| 63 |
| EG001 | 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. | 0 | 66 | 2 | 66 | 0 | 66 |
| Lupus Flare | Immune system disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Smoke Inhalation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Stroke | Vascular disorders | Non-systematic Assessment |
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| Heart Failure Complications | General disorders | Non-systematic Assessment |
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| Aortic Stenosis | Cardiac disorders | Non-systematic Assessment |
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| Bladder Obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
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| D001519 | Behavior |