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

NCT05426070 | Completed

• 1 other identifier: 580913
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Physical Inactivity; Obesity

Keywords

strength training; group-based exercise; pre-menopausal; exercise adherence

Outcome Measures

Primary Outcomes (1)

• Exercise Adherence

  Apple Watch

  from date of randomization until the date of three month assessment; up to three months

Secondary Outcomes (1)

• Weight

  from date of randomization until the date of three month assessment; up to three months

Other Outcomes (7)

• Physical Activity Enjoyment Scale (PACES)

  from date of randomization until the date of three month assessment; up to three months

• Behavioral Regulation in Exercise Questionnaire (BREQ-2)

  from date of randomization until the date of three month assessment; up to three months

• Motives for Physical Activity Measure- Revised (MPAM-R)

  from date of randomization until the date of three month assessment; up to three months

Study Arms (2)

Strength training-based exercise

EXPERIMENTAL

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

No contact, wait-list control

NO INTERVENTION

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.

Interventions

Strength training-based exercise BEHAVIORAL

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.

Strength training-based exercise

Eligibility Criteria

• Age: 40 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (4)

• Ryan, R. M., & Deci, E. L. (2002). Overview of self-determination theory: An organismic dialectical perspective. Handbook of Self-determination Research, 2, 3-33.

  BACKGROUND

• Lally P, Wardle J, Gardner B. Experiences of habit formation: a qualitative study. Psychol Health Med. 2011 Aug;16(4):484-9. doi: 10.1080/13548506.2011.555774.

  PMID: 21749245 BACKGROUND

• Thogersen-Ntoumani C, Shepherd SO, Ntoumanis N, Wagenmakers AJ, Shaw CS. Intrinsic motivation in two exercise interventions: Associations with fitness and body composition. Health Psychol. 2016 Feb;35(2):195-8. doi: 10.1037/hea0000260. Epub 2015 Sep 21.

  PMID: 26389719 BACKGROUND

• Lewis BA, Schuver KJ, Swinney KB, Dregney TM, Linde JA. Examining the feasibility and preliminary efficacy of a group-based physical activity intervention integrating strength training among pre- and perimenopausal women: A randomized pilot trial. Womens Health (Lond). 2025 Jan-Dec;21:17455057251361243. doi: 10.1177/17455057251361243. Epub 2025 Aug 10.

  PMID: 40784014 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Obesity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: December 30, 2022
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)