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

POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Intellectual Disability; Motivational Interviewing; Telehealth
• Intervention / Treatment: Behavioral: POWERSforID

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35292
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in weekly phone calls	Number of weekly intervention phone calls attended or missed	24 weeks
Number of logins to the POWERSforID website	Number of times the POWERSforID website is accessed to journal health related behaviors	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight change measured in kilograms	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity questionnaire	The questionnaire includes assessment of perceived barriers to physical activity and physical activity participation.	24 weeks
Mood/Psychosocial questionnaire	Measured by the Glasgow depression scale, Psychosocial questionnaire for individuals with ID, scale for perceived physical and nutrition related barriers	24 weeks
Dietary recall questionnaire	The questionnaire includes assessment of type of foods consumed.	24 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Neumeier WH, Guerra N, Thirumalai M, Geer B, Ervin D, Rimmer JH. POWERS forID: Personalized Online Weight and Exercise Response System for Individuals with Intellectual Disability: study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):487. doi: 10.1186/s13063-017-2239-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Body Weight Changes; Neurodevelopmental Disorders; Weight Loss; Body Weight; Intellectual Disability
• Other Study ID Numbers: F141230005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No