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OpenTrials
Completed

NCT Number: NCT03139760

POWERSforID: A Telehealth Weight Management 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.

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35292, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

POWERSforID

Behavioral

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

Primary outcomes

  1. Participation in weekly phone calls

    Time frame: 24 weeks

    Number of weekly intervention phone calls attended or missed

  2. Number of logins to the POWERSforID website

    Time frame: 24 weeks

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

Secondary outcomes

  1. Weight loss

    Time frame: 24 weeks

    Weight change measured in kilograms

Other outcomes

  1. Physical activity questionnaire

    Time frame: 24 weeks

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

  2. Mood/Psychosocial questionnaire

    Time frame: 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

    Time frame: 24 weeks

    The questionnaire includes assessment of type of foods consumed.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: POWERSforID

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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