Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD079642 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.
Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual and Developmental Disabilities (IDD) than those in the general population. Many of the negative health consequences observed in obese adults are already present in obese adolescents with IDD.
This study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. The investigators will randomize 123 overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance):
group 1) Face-To-Face/CD
group 2) Technology delivery/CD
group 3) Technology delivery/eSLD.
All participants will receive a progressive program of physical activity. Participants on the CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day.
FTF will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-To-Face/CD | Active Comparator | Delivery: Face-to-face Diet: Conventional diet |
|
| Technology delivery/CD | Experimental | Delivery: Technology Diet: Conventional diet |
|
| Technology delivery/eSLD | Experimental | Delivery: Technology Diet: enhanced Stop Light Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Stop Light Diet (eSLD) | Dietary Supplement | eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change at 6 Months | Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg. | Change in weight from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change Across 18 Months | Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg. | Change in weight from baseline to 18 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joseph E 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 | ||
| Energy Balance Lab, The University of Kansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37487764 | Derived | Bodde AE, White DA, Forseth B, Hastert M, Washburn R, Donnelly J, Sullivan D, Ptomey LT. Parent factors associated with BMI, diet, and physical activity of adolescents with intellectual and developmental disabilities. Disabil Health J. 2023 Oct;16(4):101507. doi: 10.1016/j.dhjo.2023.101507. Epub 2023 Jul 7. | |
| 36604240 | Derived | Bodde AE, Helsel BC, Hastert M, Suire KB, Washburn RA, Donnelly JE, Ptomey LT. The prevalence of obesity and lifestyle behaviors of parents of youth with intellectual and developmental disabilities. Disabil Health J. 2023 Jul;16(3):101430. doi: 10.1016/j.dhjo.2022.101430. Epub 2022 Dec 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Face-To-Face/CD | Delivery: Face-to-face Diet: Conventional diet Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Face-to-face (FTF): FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 30, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional Diet (CD) | Dietary Supplement | CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. |
|
| Face-to-face (FTF) | Behavioral | FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet. |
|
| Technology (TECH) | Behavioral | TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. |
|
| iPad with FaceTime | Other | TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. |
|
| Lawrence |
| Kansas |
| 66045 |
| United States |
| 34915594 | Derived | Ptomey LT, Lee J, White DA, Helsel BC, Washburn RA, Donnelly JE. Changes in physical activity across a 6-month weight loss intervention in adolescents with intellectual and developmental disabilities. J Intellect Disabil Res. 2022 Jun;66(6):545-557. doi: 10.1111/jir.12909. Epub 2021 Dec 16. |
| 34413247 | Derived | Ptomey LT, Washburn RA, Goetz JR, Sullivan DK, Gibson CA, Mayo MS, Krebill R, Gorczyca AM, Montgomery RN, Honas JJ, Helsel BC, Donnelly JE. Weight Loss Interventions for Adolescents With Intellectual Disabilities: An RCT. Pediatrics. 2021 Sep;148(3):e2021050261. doi: 10.1542/peds.2021-050261. Epub 2021 Aug 19. |
| FG001 |
| Technology Delivery/CD |
Delivery: Technology Diet: Conventional diet Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. |
| FG002 | Technology Delivery/eSLD | Delivery: Technology Diet: enhanced Stop Light Diet Enhanced Stop Light Diet (eSLD): eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week. Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. |
| 6 Months |
|
| 12 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Face-To-Face/CD | Delivery: Face-to-face Diet: Conventional diet Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Face-to-face (FTF): FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet. |
| BG001 | Technology Delivery/CD | Delivery: Technology Diet: Conventional diet Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. |
| BG002 | Technology Delivery/eSLD | Delivery: Technology Diet: enhanced Stop Light Diet Enhanced Stop Light Diet (eSLD): eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week. Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 at 6 Months | Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg. | Posted | Mean | Standard Deviation | kg | Change in weight from baseline to 6 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Weight Change Across 18 Months | Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg. | Posted | Mean | Standard Deviation | kg | Change in weight from baseline to 18 months |
|
Across 18 months
Not provided
Not provided
| 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/CD | Delivery: Face-to-face Diet: Conventional diet Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Face-to-face (FTF): FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet. | 0 | 36 | 0 | 36 | 0 | 36 |
| EG001 | Technology Delivery/CD | Delivery: Technology Diet: Conventional diet Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. | 0 | 39 | 0 | 39 | 5 | 39 |
| EG002 | Technology Delivery/eSLD | Delivery: Technology Diet: enhanced Stop Light Diet Enhanced Stop Light Diet (eSLD): eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week. Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet. iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. | 0 | 35 | 1 | 35 | 1 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Open Heart Surgery | Surgical and medical procedures | Non-systematic Assessment | Durning study participant discovered they had a congenital heart defect and required surgery to repair. Need for surgery was unrelated to the intervention |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broken Bone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Colonoscopy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Donnelly | University of Kansas Medical Center | 785-864-3880 | jdonnelly@ku.edu |
| Feb 7, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002658 | Developmental Disabilities |
| D015431 | Weight Loss |
| D001835 | Body Weight |
| D004314 | Down Syndrome |
| D001836 | Body Weight Changes |
| D008607 | Intellectual Disability |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013672 | Technology |
| ID | Term |
|---|---|
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|