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

NCT ID: NCT03139760

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intellectual Disability Weight Loss Motivational Interviewing Telehealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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POWERSforID

POWERSforID intervention group

Group Type EXPERIMENTAL

POWERSforID

Intervention Type BEHAVIORAL

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

Control

Usual clinical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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POWERSforID

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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".
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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James Rimmer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Rimmer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29058620 (View on PubMed)

Other Identifiers

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F141230005

Identifier Type: -

Identifier Source: org_study_id

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