CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Habit Formation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04140890
NCT04140890N/ACompleted

Supporting Habit Formation to Attenuate Prefrailty in Elders: a Pilot Study

Wayne State University·interventional·Posted Oct 28, 2019·Updated Nov 23, 2020

In Brief

A clinical study evaluating Habit Formation and Education for Frailty. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFrailty
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 28, 2019
Enrollment StartSep 30, 2019
Primary CompletionMar 30, 2020
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.7 years ago

Interventions

Habit Formationbehavioral

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.

Educationbehavioral

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.