Clinical trial NCT03139760: POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
Official title: POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Weight Loss
Motivational Interviewing
Telehealth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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".

Primary outcomes:
measure: Participation in weekly phone calls
timeFrame: 24 weeks
measure: Number of logins to the POWERSforID website
timeFrame: 24 weeks
Secondary outcomes:
measure: Weight loss
timeFrame: 24 weeks
Other outcomes:
measure: Physical activity questionnaire
timeFrame: 24 weeks
measure: Mood/Psychosocial questionnaire
timeFrame: 24 weeks
measure: Dietary recall questionnaire
timeFrame: 24 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: James Rimmer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.