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Remote Delivery of Weight Management for Adults With IDD

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ClinicalTrials.gov Identifier: NCT03291509
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Kansas Medical Center

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 21, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

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 Name: 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 Name: 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.



Primary Outcome Measures :
  1. Change in weight [ Time Frame: Change from Baseline to Month 6 ]

Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: 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).

  2. Change in weight [ Time Frame: Change from Baseline to Month 24 ]
  3. Cost analysis of study interventions [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291509


Contacts
Contact: Lauren T Ptomey, PhD, RD, LD 913-588-7983 LPtomey@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
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

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03291509     History of Changes
Other Study ID Numbers: STUDY00140653
R01DK114121-01 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
weight loss
weight management

Additional relevant MeSH terms:
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders