NCT03291509

Brief Summary

The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 21, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 7, 2023

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

September 19, 2017

Results QC Date

February 7, 2023

Last Update Submit

February 7, 2023

Conditions

Obesity

Keywords

weight lossweight management

Outcome Measures

Primary Outcomes (1)

  • Change in Weight (kg)

    Change in weight (kg) from baseline to 6 months

    Change from Baseline to Month 6

Secondary Outcomes (1)

  • Change in Weight (kg)

    Change from Baseline to Month 24

Study Arms (2)

In-person Group

ACTIVE COMPARATOR

Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.

Behavioral: In-person MeetingsBehavioral: Enhanced Stop Light DietBehavioral: Physical Activity

Computer Group

EXPERIMENTAL

Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.

Behavioral: Video Conference MeetingsBehavioral: Enhanced Stop Light DietBehavioral: Physical Activity

Interventions

Video Conference MeetingsBEHAVIORAL

Individual video conferencing with a health educator using an iPad.

Computer Group
In-person MeetingsBEHAVIORAL

Individual face-to-face (FTF) meetings with a health educator.

In-person Group
Enhanced Stop Light DietBEHAVIORAL

Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).

Also known as: eSLD
Computer GroupIn-person Group
Physical ActivityBEHAVIORAL

Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.

Computer GroupIn-person Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
  • Ability to provide assent, regardless of guardian consent.
  • BMI of 25 to 45 kg/m2
  • Sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language
  • Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
  • No plans to relocate outside the study area over the next 24 months
  • Internet access in the home

You may not qualify if:

  • Unable to participate in moderate-to-vigorous physical activity (MVPA)
  • Insulin dependent diabetes
  • Participation in a weight management program involving diet and physical activity in the past 6 months
  • Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
  • Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
  • Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty
  • Unwilling to be randomized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • Ptomey LT, Washburn RA, Sherman JR, Mayo MS, Krebill R, Szabo-Reed AN, Honas JJ, Helsel BC, Bodde A, Donnelly JE. Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial. Disabil Health J. 2024 Apr;17(2):101587. doi: 10.1016/j.dhjo.2024.101587. Epub 2024 Jan 22.

    PMID: 38272776DERIVED

  • Ptomey LT, Washburn RA, Mayo MS, Greene JL, Lee RH, Szabo-Reed AN, Honas JJ, Sherman JR, Donnelly JE. Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24 month randomized trial. Contemp Clin Trials. 2018 Oct;73:16-26. doi: 10.1016/j.cct.2018.08.010. Epub 2018 Aug 24.

    PMID: 30145269DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Lauren Ptomey
Organization
University of Kansas Medical Center
lptomey@kumc.edu
913-588-7983

Study Officials

  • Joseph Donnelly, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

  • Lauren T Ptomey, PhD, RD, LD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 25, 2017

Study Start

February 21, 2018

Primary Completion

March 16, 2021

Study Completion

August 14, 2022

Last Updated

March 7, 2023

Results First Posted

March 7, 2023

Record last verified: 2023-02

Locations

US(1)