Remote Delivery of Weight Management for Adults With IDD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2022-08-14

Brief Summary

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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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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

In-person Meetings

Intervention Type BEHAVIORAL

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

Enhanced Stop Light Diet

Intervention Type 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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Video Conference Meetings

Intervention Type BEHAVIORAL

Individual video conferencing with a health educator using an iPad.

Enhanced Stop Light Diet

Intervention Type 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

Intervention Type 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.

Interventions

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Video Conference Meetings

Individual video conferencing with a health educator using an iPad.

Intervention Type BEHAVIORAL

In-person Meetings

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

Intervention Type 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.).

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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eSLD

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No