Preliminary Efficacy of a Strength Training Intervention on Exercise Adherence and Weight Among Pre-Menopausal Women

January 4, 2024 updated by: University of Minnesota
The purpose of this study is to examine the feasibility and acceptability of a strength training-based intervention on exercise adherence among low active (defined as engaging in physical activity 90 minutes or less per week), pre-menopausal women ages 40-50, along with the effect on weight and various psychosocial measures. Participants will be randomly assigned to a strength training-based intervention or a wait-list control each lasting three months (participants in the no contact, wait-list control condition will have the option of receiving the strength training-based intervention following the three months).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomly assigned to a strength training-based exercise intervention or a no contact, wait-list control each lasting three months (participants in the no contact, wait-list control will have the option of receiving the strength training-based intervention following the three months). The strength training-based exercise intervention will be delivered via group-based Zoom sessions, motivational email messages, and a website. Participants will take part in two group-based Zoom exercise sessions (40-minute exercise sessions and 20 minutes of motivational counseling) and two individual exercise sessions per week for six months. Exercise sessions will include a combination of various aerobic (e.g., jogging in place, high knees) and muscle strengthening exercises (e.g., burpees, push-ups, lunges, body weight squats) designed to keep heart rate in the 60-85% range of maximum heart rate. Participants will choose from a variety of options for their two individual sessions (e.g., online exercise video, jogging or walking outside, prescribed exercise session listed on the website, or any other exercise) and modifications for each exercise will be made depending on the participant's ability and current fitness and strength level (e.g., wall push-ups vs. knee push-ups vs. regular push-ups). Participants will be instructed to stop exercising if problems occur and will receive training and handouts on how to recognize problems such as angina and myocardial infarction symptoms.

Self-Determination Theory (SDT) and habit formation theory will guide the content of the counseling portion of the Zoom sessions and the motivational features of the study website and text messages. Motivational counseling will be focused on increasing motivation to exercise and habit formation. The goal is to achieve integrated regulation and therefore, the health counselor will focus on positive affective response to exercise sessions and discuss how being physically active is becoming part of their self-identity. The goal will be high intrinsic motivation (i.e., individuals engage in exercise due to inherent pleasure) since it is related to higher levels of exercise. Strength training-based participants will also receive access to a mobile phone-friendly study website and will receive emails. Both the website and email messages will contain motivational content to complete the exercise sessions. The motivational website will also include an online log to track completion of home-based sessions and options for individual-based exercise sessions.. Assessment of exercise adherence, weight, and psychosocial variables will occur at baseline and three months.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1) pre-menopausal women ages 40-50 years; (2) engaging in 90 minutes or less of exercise per week; (3) no exercise contraindications; (4) adequate space at home to complete exercise sessions and capacity to use Zoom via a mobile device or computer; (5) available to attend two zoom-based sessions a week; (6) be able to read, understand, and speak in the English language (7) willing to be randomly assigned to either study condition (8) access to iPhone 8 or later with iOS 16 or later

Exclusion Criteria:

  • Specific exclusion criteria will include a history of coronary heart disease (history of myocardial infarction, symptoms of angina), orthopedic problems that would limit physical activity participation, diabetes, stroke, osteoarthritis, and any other medical condition that may make physical activity unsafe or unwise. Other exclusion criteria will include current or planned pregnancy, psychosis or current suicidal ideation, and psychiatric hospitalization within the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strength training-based exercise
The strength training-based exercise intervention will be delivered via group-based Zoom sessions, motivational text messages, and a website. Participants will take part in two group-based Zoom exercise sessions (40-minute exercise sessions and 20 minutes of motivational counseling) and two individual exercise sessions per week for three months. Exercise sessions will include a combination of various aerobic and muscle strengthening exercises designed to keep heart rate in the 60-85% range of maximum heart rate. Motivational counseling will be focused on increasing motivation to exercise and habit formation. Strength training-based participants will also receive access to a mobile phone-friendly study website and will receive email messages. Both the website and email messages will contain motivational content to complete the exercise sessions.
Behavioral: Strength training-based exercise
Participants will take part in two group-based Zoom exercise sessions and two individual exercise sessions per week for three months. Exercise sessions will include a combination of various aerobic (e.g., jogging in place, high knees) and muscle strengthening exercises (e.g., burpees, push-ups, lunges, body weight squats) designed to keep heart rate in the 60-85% range of maximum heart rate. Participants will choose from a variety of options for their two individual sessions (e.g., online exercise video, jogging or walking outside, prescribed exercise session listed on the website, or any other exercise) and modifications for each exercise will be made depending on the participant's ability and current fitness and strength level. Participants will be instructed to stop exercising if problems occur and will receive training and handouts on how to recognize problems such as angina and myocardial infarction.
No Intervention: No contact, wait-list control
Participants in the no contact, wait-list control intervention will participate in assessments at baseline and three months. Following the six month assessment, participants will have the option of receiving the strength training-based intervention as described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Adherence
Time Frame: from date of randomization until the date of three month assessment; up to three months
Apple Watch
from date of randomization until the date of three month assessment; up to three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: from date of randomization until the date of three month assessment; up to three months
Withings Smart Scale
from date of randomization until the date of three month assessment; up to three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Enjoyment Scale (PACES)
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; Physical Activity Enjoyment Scale (PACES) is an 18 item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale from 1 (I enjoy it) to 7 (I hate it). Higher scores indicate higher enjoyment with range of 18-126 being possible.
from date of randomization until the date of three month assessment; up to three months
Behavioral Regulation in Exercise Questionnaire (BREQ-2)
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; the Behavioral Regulation in Exercise Questionnaire (BREQ-2) is a 19-item questionnaire that includes five subscales (intrinsic motivation, identified regulation, introjected regulation, external regulation, and amotivation. This scale is on a 5 point Likert scale ranging from 0 (not true for me) to 4 (very true for me). The minimum score is -24 and the maximum score is +20. Higher positive scores indicate more autonomous motivation whereas lower negative scores indicate less autonomous motivation.
from date of randomization until the date of three month assessment; up to three months
Motives for Physical Activity Measure- Revised (MPAM-R)
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; the Motives for Physical Activity Measure- Revised (MPAM-R) is a 30-item scale that examines five motives for physical activity participation including enjoyment/interest, competence/challenge, social interaction, appearance, and fitness. Composed of 30 items, 7-point Likert scale with 1= not at all true for me to 7= very true for me. Maximum score=210; minimum score=30. Higher score=higher motivation.
from date of randomization until the date of three month assessment; up to three months
Physical Activity Self-Efficacy
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; physical activity self-efficacy measuring how confident of exercise. 5 items. 5-point Likert scale with 1=not at all confident to 5= extremely confident. Maximum value of 25, minimum value of 5 with higher scores indicating higher level of self-efficacy
from date of randomization until the date of three month assessment; up to three months
Outcome Expectations or Exercise
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; Outcome Expectations for Exercise measures the degree to which individuals agree to statements regarding benefits of exercise. 9 items. 5-point Likert scale with 1= strongly disagree to 5= strongly agree. Maximum value= 45; minimum value= 9 with higher score indicating higher outcome expectations related to exercise.
from date of randomization until the date of three month assessment; up to three months
Social Support for Physical Activity
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; Social Support for Physical Activity measures perceived social support based on two subscales; family and friends. 13 items. 5-point Likert scale with 0=none and 4=very often. Maximum score= 52; minimum score=0. Higher levels indicate higher level of perceived social support for physical activity.
from date of randomization until the date of three month assessment; up to three months
Exercise Feeling Inventory Survey
Time Frame: from date of randomization until the date of three month assessment; up to three months
questionnaire; Exercise Feeling Inventory Survey (EFI) measures feeling states that occur during acute PA bouts. Four feeling states are assessed including revitalization, positive engagement, physical exhaustion, and tranquility. 12 items. 5-point Likert scale; 0= do not feel and 4=feel very strongly. Maximum Score= 48; minimum score=0. Higher score= higher feeling.
from date of randomization until the date of three month assessment; up to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2022

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 580913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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