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Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study

NCT04140890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-23

Study results available
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Summary

The Supporting Habit Formation to Attenuate Prefrailty in Elders (SHAPE) Pilot Study is a randomized control study. The main objective of this pilot study is to determine the feasibility of using Habit Formation (HF) treatment to increase Physical Activity (PA) (reduction in daily in hours of sedentary time), and dietary among prefrail African Americans. We hypothesize: (1)The SHAPE study will demonstrate good feasibility with a high recruitment rate and successful administration all of the measures among the target population; (2) Treatment group participants will demonstrate greater increases in primary outcomes (physical activity level and dietary quality) and secondary outcomes (quality of life, depressive symptoms, prefrailty reduction, lower extremity strength and balance, physical activity level, waist circumference, and weight at intervention completion.

Conditions

Interventions

BEHAVIORAL

Habit Formation

Treatment sessions consist of 12 weekly health coaching sessions at participants' home. During the intervention period, an occupational therapist will help the participant to commit to developing new simple habits (dietary habits or physical activity habits) in each 60-minute session.

BEHAVIORAL

Education

In the education group, participants will receive newsletters containing general healthy aging materials over 12 weeks. A trained research assistant will call participants to verify receipt of the newsletter, and answer their questions about the materials. Each phone call will last \~15 minutes.

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Heather Fritz, PhD · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-03-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04140890 on ClinicalTrials.gov