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Trial record 22 of 214 for:    Developmental Disabilities | NIH

Remote Delivery of Weight Management for Adults With IDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291509
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE September 19, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE February 21, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
Change in weight [ Time Frame: Change from Baseline to Month 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03291509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
  • 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).
  • Change in weight [ Time Frame: Change from Baseline to Month 24 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Delivery of Weight Management for Adults With IDD
Official Title  ICMJE Remote Delivery of Weight Management for Adults With Intellectual and Developmental Disabilities (IDD)
Brief Summary The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Video Conference Meetings
    Individual video conferencing with a health educator using an iPad.
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: In-person Meetings
    • Behavioral: Enhanced Stop Light Diet
    • Behavioral: Physical Activity
  • 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.
    Interventions:
    • Behavioral: Video Conference Meetings
    • Behavioral: Enhanced Stop Light Diet
    • Behavioral: Physical Activity
Publications * Ptomey LT, Washburn RA, Mayo MS, Greene JL, Lee RH, Szabo-Reed AN, Honas JJ, Sherman JR, Donnelly JE. Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial. Contemp Clin Trials. 2018 Oct;73:16-26. doi: 10.1016/j.cct.2018.08.010. Epub 2018 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren T Ptomey, PhD, RD, LD 913-588-7983 LPtomey@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03291509
Other Study ID Numbers  ICMJE STUDY00140653
R01DK114121-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Joseph Donnelly, PhD University of Kansas Medical Center
Principal Investigator: Lauren T Ptomey, PhD, RD, LD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP