NCT03444129

Brief Summary

Broad, diverse, and innovative efforts are needed to address the growing dual public health challenges of obesity and diabetes, especially for those at increased risk like minority older adults. The emerging field of health games offers an innovative opportunity to reach populations to provide healthy eating and physical activity messages. Little research has focused on the use of health games specifically tailored for older adults. This study builds upon a health game designed to provide knowledge, facilitate movement, enhance motivation, and encourage healthy eating (HE) and physical activity (PA) behaviors in youth. This study will adapt, implement, and evaluate the feasibility, acceptability, adherence, and preliminary outcomes of the game among overweight/obese African American older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

November 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

April 16, 2020

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

November 15, 2017

Last Update Submit

April 14, 2020

Conditions

Health BehaviorHealth Attitude

Outcome Measures

Primary Outcomes (3)

  • Eating habits

    Eating habits will be assessed using the Visually-Enhanced Food Behavior Checklist.

    6 weeks

  • Physical activity patterns

    Physical activity patterns will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ).

    6 weeks

  • Motivation

    Behavioral motivation questions will include Stage of change and confidence items to assess motivation (i.e., readiness) or achievement of behavioral goals.

    6 weeks

Secondary Outcomes (5)

  • Weight

    6 weeks

  • Adherence

    6 weeks

  • Short International Physical Activity Questionnaire

    6 weeks

  • MPP Acceptability Survey

    6 weeks

  • MPP stages of change survey

    6 week s

Study Arms (2)

Control

ACTIVE COMPARATOR

This group will participate in a health education workshop with weekly sessions (control group)

Behavioral: Healthy eating workshop

Game

EXPERIMENTAL

This group will participate in the health education workshop plus the interactive health game (intervention group).

Behavioral: Healthy eating workshop and interactive health game

Interventions

Healthy eating workshop and interactive health gameBEHAVIORAL

The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop and interactive health game. Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.

Game
Healthy eating workshopBEHAVIORAL

The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop. Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.

Control

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 50 and 65 years
  • Overweight or obese (25kg/m2 ≤ BMI \< 40kg/m2)
  • African American/Black by self-report
  • Risk factors for diabetes (based on adapted ADA risk test)

You may not qualify if:

  • Adults with cognitive impairments, based on the adapted Mental Status Questionnaire (MSQ).
  • Health conditions that preclude participation in physical activity program, based on the Exercise Assessment and Screener for You (EASY) physical activity screener.
  • Already diagnosed with diabetes by self-report
  • Currently engaging in vigorous physical activity
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Amparo Castillo, PhD

    UIC

    PRINCIPAL INVESTIGATOR

  • Laurie Ruggiero, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Training and Research Coordinator

Study Record Dates

First Submitted

November 15, 2017

First Posted

February 23, 2018

Study Start

January 20, 2018

Primary Completion

March 10, 2018

Study Completion

May 31, 2018

Last Updated

April 16, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)