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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK114121-01 | 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 purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person Group | Active Comparator | Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. |
|
| Computer Group | Experimental | Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Conference Meetings | Behavioral | Individual video conferencing with a health educator using an iPad. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight (kg) | Change in weight (kg) from baseline to 6 months | Change from Baseline to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight (kg) | Change in weight across the 24 month study | Change from Baseline to Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Donnelly, PhD | University of Kansas Medical Center | Principal Investigator |
| Lauren T Ptomey, PhD, RD, LD | 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 |
|---|---|---|---|
| 38272776 | Derived | Ptomey LT, Washburn RA, Sherman JR, Mayo MS, Krebill R, Szabo-Reed AN, Honas JJ, Helsel BC, Bodde A, Donnelly JE. Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial. Disabil Health J. 2024 Apr;17(2):101587. doi: 10.1016/j.dhjo.2024.101587. Epub 2024 Jan 22. | |
| 30145269 | Derived | Ptomey LT, Washburn RA, Mayo MS, Greene JL, Lee RH, Szabo-Reed AN, Honas JJ, Sherman JR, Donnelly JE. Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial. Contemp Clin Trials. 2018 Oct;73:16-26. doi: 10.1016/j.cct.2018.08.010. Epub 2018 Aug 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Face to Face | Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. In-person Meetings: Individual face-to-face (FTF) meetings with a health educator. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
| FG001 | Remote Delivery | Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. Video Conference Meetings: Individual video conferencing with a health educator using an iPad. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Face to Face | Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. In-person Meetings: Individual face-to-face (FTF) meetings with a health educator. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
| 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, Continuous | Mean |
| 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 | Change in Weight (kg) | Change in weight (kg) from baseline to 6 months | Posted | Mean | Standard Deviation | kg | Change from Baseline to Month 6 |
|
2 years
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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 | Face to Face | Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. In-person Meetings: Individual face-to-face (FTF) meetings with a health educator. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Choking |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken Bone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Ptomey | University of Kansas Medical Center | 913-588-7983 | lptomey@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 | Mar 20, 2020 | Feb 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| In-person Meetings | Behavioral | Individual face-to-face (FTF) meetings with a health educator. |
|
| Enhanced Stop Light Diet | Behavioral | Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). |
|
|
| Physical Activity | Behavioral | Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
|
| BG001 | Remote Delivery | Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. Video Conference Meetings: Individual video conferencing with a health educator using an iPad. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
| BG002 | Total | Total of all reporting groups |
| 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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| Weight (kg) | Mean | Standard Deviation | kg |
|
| OG001 | Remote Delivery | Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. Video Conference Meetings: Individual video conferencing with a health educator using an iPad. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. |
|
|
| Secondary | Change in Weight (kg) | Change in weight across the 24 month study | Posted | Mean | Standard Deviation | kg | Change from Baseline to Month 24 |
|
|
|
| 1 |
| 60 |
| 1 |
| 60 |
| 3 |
| 60 |
| EG001 | Remote Delivery | Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week. Video Conference Meetings: Individual video conferencing with a health educator using an iPad. Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.). Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. | 0 | 60 | 1 | 60 | 3 | 60 |
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Muscle Strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |