POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT03139760
Collaborator
(none)
36
1
2
25
1.4

Study Details

Study Description

Brief Summary

POWERSforID is a 24 week randomized control trial designed to assess the feasibility of a telehealth and coaching intervention for improving health outcomes of adults with intellectual disability. Recruitment is conducted through a disability health clinic located in Colorado Springs, CO.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: POWERSforID
N/A

Detailed Description

POWERS (Personalized Online Weight and Exercise Response System) platform is a novel, multifocal-centered tailored intervention utilizing an innovative online tool designed to facilitate improvements in physical activity and nutritional behaviors. Aim 1 of this protocol is to customize the POWERS platform, demonstrated effective in previous research, for adults with intellectual disability (ID) and their caregivers to be referred to as POWERSforID. The POWERSforID intervention is designed to achieve weight loss and improve specific health markers while respecting and supporting the needs of the participants with ID as well as their caregivers. Aim 2 of the project is to conduct a pilot study to assess the usability and feasibility of the POWERSforID system and intervention with 5 adults with ID and their caregiver and improve the system based on pilot data. Aim 3 of the protocol is to conduct a randomized controlled trial (RCT) to examine the effect of POWERSforID on educating and coaching caregivers about nutrition and exercise and thus improving health status and reducing body weight in obese adults with ID. The investigators hypothesize that the obese participants in the intervention group (POWERSforID) will evidence significantly greater weight loss and improved health status (i.e. lower waist circumference, blood pressure, decreased body fat percentage, and improved blood lipids) compared to a control group. The investigators also hypothesize that both adults with ID and their caregivers will demonstrate improved knowledge, attitudes, and self-efficacy related to diet and exercise.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Health Services Research
Official Title:
POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: POWERSforID

POWERSforID intervention group

Behavioral: POWERSforID
Feasibility and outcomes associated with use of the POWERSforID system and coaching phone calls over the course of 24 weeks

No Intervention: Control

Usual clinical care

Outcome Measures

Primary Outcome Measures

  1. Participation in weekly phone calls [24 weeks]

    Number of weekly intervention phone calls attended or missed

  2. Number of logins to the POWERSforID website [24 weeks]

    Number of times the POWERSforID website is accessed to journal health related behaviors

Secondary Outcome Measures

  1. Weight loss [24 weeks]

    Weight change measured in kilograms

Other Outcome Measures

  1. Physical activity questionnaire [24 weeks]

    The questionnaire includes assessment of perceived barriers to physical activity and physical activity participation.

  2. Mood/Psychosocial questionnaire [24 weeks]

    Measured by the Glasgow depression scale, Psychosocial questionnaire for individuals with ID, scale for perceived physical and nutrition related barriers

  3. Dietary recall questionnaire [24 weeks]

    The questionnaire includes assessment of type of foods consumed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Participants with intellectual disability (ID) who meet the following inclusion criteria are eligible to participate in the study:

  • Body Mass Index > or equal to 30 kg/m2;

  • Diagnosis of mild or moderate ID;

  • 25 to 50 years of age;

  • Medical provider approval to participate in a weight loss program;

  • Has a caregiver who agrees to participate in the study and provides services 4 days a week or more to the adult with ID;

  • Has access to a computer with internet throughout the week.

Exclusion Criteria:
  • Currently on a weight loss program;

  • Medical conditions that prevent participation as noted by the medical provider or legal guardian including heart and/or renal disease;

  • Behavioral issues determined by the DDHC Behavioral Health staff;

  • Unable to walk or exercise due to a mobility impairment or medical condition;

  • Judged to have insufficient capacity to consent or assent as assessed using the "Supplemental Consent Document".

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35292

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: James Rimmer, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Rimmer, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03139760
Other Study ID Numbers:
  • F141230005
First Posted:
May 4, 2017
Last Update Posted:
Nov 15, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2018