Remote Delivery of Weight Management for Adults With IDD

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03291509

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

120

Enrollment

Location

Arms

54.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Video Conference Meetings Behavioral: In-person Meetings Behavioral: Enhanced Stop Light Diet Behavioral: Physical Activity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)

Actual Study Start Date :

Feb 21, 2018

Actual Primary Completion Date :

Mar 16, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: In-person Group 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.	Behavioral: In-person Meetings Individual face-to-face (FTF) meetings with a health educator. Behavioral: 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.). Other Names: eSLD Behavioral: 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.
Experimental: Computer Group 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.	Behavioral: Video Conference Meetings Individual video conferencing with a health educator using an iPad. Behavioral: 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.). Other Names: eSLD Behavioral: 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.

Arm

Intervention/Treatment

Active Comparator: In-person Group

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.

Behavioral: In-person Meetings

Individual face-to-face (FTF) meetings with a health educator.

Behavioral: 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.).

Other Names:

eSLD

Behavioral: 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.

Experimental: Computer Group

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.

Behavioral: Video Conference Meetings

Individual video conferencing with a health educator using an iPad.

Behavioral: Enhanced Stop Light Diet

Other Names:

eSLD

Behavioral: Physical Activity

Outcome Measures

Primary Outcome Measures

Change in weight [Change from Baseline to Month 6]

Secondary Outcome Measures

Change in Quality of Life [Change from Baseline to Month 24]
Quality of life will be assessed with the Personal Well-Being Index-Intellectual Disability. It is an 8 question Likert scale survey that uses faces that range from unhappy to very happy to determine how satisfied a person is with their life. Each question can be scored on scale from 0-4. This is then converted to a total score out of 100 points. The normative range for individuals is 50-100. Higher scores are indicative of a higher perceived quality of life (happiness with current life situations).
Change in weight [Change from Baseline to Month 24]
Cost analysis of study interventions [Month 24]
Data will be collected on both program (health educator time, supplies, iPads) and participant/study partner costs (time), prospectively. Participant and study partner time will be valued at the local median hourly wage. These costs, will be gathered via survey. We will conduct sensitivity analyses that vary the value of participant/study partner time from $0.00 to the median hourly wage.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
Ability to provide assent, regardless of guardian consent.
BMI of 25 to 45 kg/m2
Sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language
Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
No plans to relocate outside the study area over the next 24 months
Internet access in the home

Exclusion Criteria:

Unable to participate in moderate-to-vigorous physical activity (MVPA)
Insulin dependent diabetes
Participation in a weight management program involving diet and physical activity in the past 6 months
Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty
Unwilling to be randomized.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Joseph Donnelly, PhD, University of Kansas Medical Center
Principal Investigator: Lauren T Ptomey, PhD, RD, LD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT03291509

Other Study ID Numbers:

STUDY00140653
R01DK114121-01

First Posted:

Sep 25, 2017

Last Update Posted:

May 6, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Kansas Medical Center

weight loss

weight management

Study Results

No Results Posted as of May 6, 2021