Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study

NCT04140890 | Completed Results

• 1 other identifier: 065319B3E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Frailty

Keywords

prefrail; habit; exercise; diet

Outcome Measures

Primary Outcomes (3)

• Number of Participants Completed the Study

  The number of participants completed the intervention and post-test.

  baseline to 6 months

• Seven-days Average Sedentary Time (Minutes/Day)

  A physical activity tracking system activPAL™. The ActivPal sensor will be attached to participants' thigh for 7 consecutive days.

  baseline to 14 weeks

• Healthy Eating Index Score

  ASA 24 is a web-based tool for participants to recall their diet on a daily basis. The HEI score is calculated by a standard SAS code provided by ASA 24 website to evaluated the content of participants' dietary recalls. Scores range from 1-100 with higher scores indicating better quality diet.

  Baseline to 14th week

Secondary Outcomes (7)

• The The World Health Organization Quality of Life- BREF

  Baseline to 14th week

• Geriatric Depression Short Form (GDS)

  Baseline to 14th week

• The Fried's Frailty Criteria Index

  Baseline to 14th week

• Short Physical Performance Battery (SPPB)

  Baseline to 14th week

• The Community Healthy Activities Model Program for Seniors (CHAMPS)

  Baseline to 14th week

Other Outcomes (2)

• The Canadian Occupational Performance Measure (Treatment Group Only) (COPM) for Treatment Group Only

  Pre-test to week 13

• The Modified Self-reported Habit Index (Treatment Group Only)

  baseline to two weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Participants in the treatment group will be asked to meet with an occupational therapist in their home weekly over 12 weeks. Each session takes an hour. In the first session, the occupational therapist will introduce the program. In session 2, the therapist will discuss pain and pain management with the participant. In session 3-12, the therapist will help the participant to develop physical activity and healthy eating habits. In each session the participant will pick two healthy behaviors to turn them into a habit. The therapist will give the participant a workbook and teach the participant to track his/her progress. The focus of session 3-5 will be physical activity, and session 6-11 will be healthy eating. In the last session (session 12), the therapist will wrap up the program and help the participant to develop a maintenance plan.

Behavioral: Habit Formation

Control

PLACEBO COMPARATOR

Participants in the control group will receive newsletters focused on general healthy aging topics over 12 weeks. With the exception of two, 1-page handouts covering PA and dietary recommendations, the weekly content will not overlap with the treatment content. Within 4 days of mailing the newsletter, a trained research assistant (RA) will call the participant, verify receipt of the newsletter, and ask them if they have any questions about the materials. The phone call will last \~15 minutes. Control condition participants receive no further intervention.

Behavioral: Education

Interventions

Habit Formation BEHAVIORAL

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.

Treatment

Education BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• Community-dwelling
• Prefrail (evaluated by the Frailty scale)
• Self-identify as African Americans.

You may not qualify if:

• Diagnosed psychiatric disorders,
• Moderate or severe cognitive impairment (using the Six Item Cognitive Impairment Test and operationalized as a score of ≥ 10),
• Using prescription drugs that could affect cognition and functioning (e.g., neuroleptics), - - Individuals with typical daily pain ratings of ≥ 7/10 on a 10 point Likert scale of pain
• Planing to change residences during the study period
• Relying on a wheelchair for home or community mobility
• Actively receiving home care services, occupational, or physical therapy
• On dialysis or who have an end of stage disease (e.g., stage IV heart failure)
• Enrolling in a health promotion program focused on physical activity and diet
• Have a baseline healthy eating index score of ≥ 85/100 as their diet would already be very close to ideal (average score for U.S. population = 59)

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Eugene Applebaum College of Pharmacy and Health Sciences

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Frailty; Habits; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Yi-Ling Hu
• Organization: Wayne State University

ha1124@wayne.edu

3142039991

Study Officials

• Heather Fritz, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: The treatment group will receive healthy habit intervention, and the control group will receive attention control.

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 28, 2019
• Study Start: September 30, 2019
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)