Feasibility, Acceptability, and Preliminary Efficacy of a Six-week Physical Activity Intervention for Black Women

NCT05997888 | Completed

• 1 other identifier: STUDY00019542
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will be a randomized controlled pilot study conducted in the Midwest. Participants will be randomly assigned to a behavioral intervention or a wait-list control group, each lasting six weeks. The intervention group will first have an in-person meeting at the beginning of the intervention to discuss the study, go over movements, and discuss Zoom and WhatsApp instructions. The behavioral intervention will consist of three home-based workouts per week sent digitally and Zoom session per week that will have an exercise session and a group counseling session. Additionally, each week participants will be sent a motivational prompt via WhatsApp and will be encouraged to connect with each other about physical activity motivation, barriers, and facilitators. Acceptability, physical activity and psychosocial variables of interest will be measured via accelerometer data (via Actigraph GT3X) and self-report at baseline and six weeks (post-intervention). Focus groups will be conducted for all participants at the conclusion of the study to further assess acceptability, feasibility, and efficacy of the program.

Conditions

Physical Inactivity

Outcome Measures

Primary Outcomes (2)

• Feasibility of the programs

  Customer satisfaction. Feasibility of the intervention will be measured by looking at acceptability and implementation of the intervention. Level of acceptability will be assessed by examining the percentage of Zoom sessions (both group and individual) attended and self-reported number of exercise sessions completed per week. This measure will be assessed on a 1-7 point Likert scale, with one = "very dissatisfied" to seven = "very satisfied". Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.

  Six weeks

• Acceptability

  Acceptability will also be assessed with a customer satisfaction form, which asks participants to respond on a seven-point Likert scale, with one = "very dissatisfied" to seven = "very satisfied". Participants will be asked to rate their satisfaction on a variety of elements such as Zoom sessions, weekly WhatsApp messages, and the overall program.

  Six weeks

Secondary Outcomes (6)

• Social support

  six weeks

• Behavioral regulation

  six weeks

• Enjoyment

  six weeks

• outcome expectations

  six weeks

• self-efficacy

  six weeks

Other Outcomes (4)

• Themes from focus groups

  six weeks

• Everyday discrimination

  baseline

• Hair type and hairstyle management

  baseline and six weeks

Study Arms (2)

At-Home Strength Training Group

EXPERIMENTAL

Participants in this arm will undergo an in-person meeting before the start of the study to meet each other, go over movements to minimize risk of injury, and to discuss intervention logistics. Then, for six weeks, participants will be sent five workouts at the start of each week (Monday). Participants will choose 2 or 3 to complete on their own. Additionally, participants will have a weekly Zoom meeting in which 30 minutes will be dedicated to exercising, and 30 minutes will be for group counseling.

Behavioral: At-Home Strength Training Intervention

Wait-List Control Group

NO INTERVENTION

This will be a wait-list control group. Participants at the end of the study will have the option to complete the full, partial, or none of the intervention.

Interventions

At-Home Strength Training Intervention BEHAVIORAL

A six-week strength training intervention in which participants will choose workouts to complete on their own. These workouts are 20-25 minutes light-intensity strength training with light strength bands. Exercises will have multiple options to account for various levels of ability. Additionally, there will be a group counseling session once per week via Zoom and a group strength training program.

At-Home Strength Training Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as a woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as Black
• Be categorized as insufficiently active, defined as less than 90 minutes of physical activity and less than two days of strength training
• Live in the Twin Cities area
• Be at least 18 years-old
• Be able to participate in the study for six weeks and agree to participate in a focus group at the conclusion of the study
• Possess a smartphone
• Be willing to wear an accelerometer (Actigraph GT3X) for the duration of the study
• Be able to attend a weekly 60 minute Zoom session on one of two selected nights
• Be willing to be randomized to the intervention or control condition.

You may not qualify if:

• Do not identify as Black
• Are active over 90 minutes per week
• Are under 18 years-old
• Will be unable to participate in the full study
• Do not possess a smartphone
• Are unwilling to wear an accelerometer
• Are unwilling to be randomized to either condition
• Are pregnant
• Have a serious physical or mental condition that would interfere with the ability to do physical activity
• Are currently enrolled in another exercise-related study.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 18, 2023
• Study Start: November 27, 2023
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)