Trial Outcomes & Findings for Weight Management for Adolescents With IDD (NCT NCT02561754)
NCT ID: NCT02561754
Last Updated: 2023-02-10
Results Overview
Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Change in weight from baseline to 6 months
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
39
|
35
|
|
Overall Study
6 Months
|
35
|
39
|
30
|
|
Overall Study
12 Months
|
32
|
34
|
26
|
|
Overall Study
COMPLETED
|
30
|
33
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Management for Adolescents With IDD
Baseline characteristics by cohort
| Measure |
Face-To-Face/CD
n=36 Participants
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.
|
Technology Delivery/CD
n=39 Participants
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.
|
Technology Delivery/eSLD
n=35 Participants
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.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.3 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
15.6 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
16.7 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
16.2 years
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
88.4 kg
STANDARD_DEVIATION 29.5 • n=5 Participants
|
74.9 kg
STANDARD_DEVIATION 16.5 • n=7 Participants
|
83.6 kg
STANDARD_DEVIATION 26.4 • n=5 Participants
|
81.9 kg
STANDARD_DEVIATION 26.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change in weight from baseline to 6 monthsParticipants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg.
Outcome measures
| Measure |
Face-To-Face/CD
n=35 Participants
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.
|
Technology Delivery/CD
n=39 Participants
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.
|
Technology Delivery/eSLD
n=30 Participants
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.
|
|---|---|---|---|
|
Weight Change at 6 Months
|
-0.3 kg
Standard Deviation 5.0
|
-1.8 kg
Standard Deviation 4.0
|
-5.0 kg
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Change in weight from baseline to 18 monthsParticipants 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.
Outcome measures
| Measure |
Face-To-Face/CD
n=30 Participants
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.
|
Technology Delivery/CD
n=33 Participants
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.
|
Technology Delivery/eSLD
n=26 Participants
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.
|
|---|---|---|---|
|
Weight Change Across 18 Months
|
1.4 kg
Standard Deviation 9.7
|
-0.2 kg
Standard Deviation 6.6
|
-2.2 kg
Standard Deviation 7.4
|
Adverse Events
Face-To-Face/CD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Technology Delivery/CD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Technology Delivery/eSLD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Face-To-Face/CD
n=36 participants at risk
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.
|
Technology Delivery/CD
n=39 participants at risk
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.
|
Technology Delivery/eSLD
n=35 participants at risk
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.
|
|---|---|---|---|
|
Surgical and medical procedures
Open Heart Surgery
|
0.00%
0/36 • Across 18 months
|
0.00%
0/39 • Across 18 months
|
2.9%
1/35 • Number of events 1 • Across 18 months
|
Other adverse events
| Measure |
Face-To-Face/CD
n=36 participants at risk
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.
|
Technology Delivery/CD
n=39 participants at risk
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.
|
Technology Delivery/eSLD
n=35 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Broken Bone
|
0.00%
0/36 • Across 18 months
|
7.7%
3/39 • Across 18 months
|
2.9%
1/35 • Across 18 months
|
|
Surgical and medical procedures
Colonoscopy
|
0.00%
0/36 • Across 18 months
|
2.6%
1/39 • Across 18 months
|
0.00%
0/35 • Across 18 months
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/36 • Across 18 months
|
2.6%
1/39 • Across 18 months
|
0.00%
0/35 • Across 18 months
|
Additional Information
Dr. Joseph Donnelly
University of Kansas Medical Center
Phone: 785-864-3880
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place