A Novel Approach to Reducing Adiposity Among Young Men

NCT04267263 | Completed

• 1 other identifier: HM20015458
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out whether a primarily self-guided program can produce changes in weight, body fat and cardiovascular risk among young men.

Conditions

Weight Loss; Men; Lifestyle Risk Reduction; Cardiovascular Diseases; Obesity

Outcome Measures

Primary Outcomes (1)

• Percent weight lost

  Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight \*100

  3 months

Secondary Outcomes (4)

• Change in perceived risk for heart disease

  Baseline to 3 months

• Change in minutes of moderate to vigorous physical activity

  Baseline to 3 months

• Change in diet quality

  Baseline to 3 months

• Change in sleep quality

  Baseline to 3 months

Study Arms (2)

Delayed Treatment Control group

NO INTERVENTION

Participants will receive the treatment after completion of the 3-month follow-up assessment

Lifestyle group

EXPERIMENTAL

Participants will receive the treatment immediately

Behavioral: Self-guided lifestyle intervention

Interventions

Self-guided lifestyle intervention BEHAVIORAL

The intervention will consist of one 60-minute group based online session, adapted specifically for young men based previous work with young adults, followed by a self-guided program for 12-weeks. Participants will receive a tool kit that includes evidence-based resources (scale for self-weighing, handouts that will include free self-monitoring apps and strategies for no-cost exercise, sample meal plans and meal planning tips, and tips for healthy living that emphasize risk areas) to assist them during the self-guided phase, as well as weekly health risk text messages.

Lifestyle group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Self-identified males
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• self-identify as a man
• years old
• BMI 25-45kg/m2
• Live in North America

You may not qualify if:

• an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
• a diagnosis of Type 1 or Type 2 diabetes
• report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen
• currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
• change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
• have lost \> 5% body weight within the last 3 months
• report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
• report hospitalization for a psychiatric condition within the last year
• report high alcohol intake (AUDIT score \> 16).
• are not able to speak and read English
• do not possess a mobile device or are unwilling to use it to receive study text messages
• Given strict data regulations outside of North America (i.e., Europe), we will only include participants living in North America (i.e., United States, Canada).

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• Reading JM, Crane MM, Guan J, Jackman R, Thomson MD, LaRose JG. Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings. JMIR Form Res. 2024 Apr 5;8:e53841. doi: 10.2196/53841.

  PMID: 38578686 DERIVED

• Reading JM, Crane MM, Carlyle K, Perera RA, LaRose JG. A Self-Guided Lifestyle Intervention for Young Men: Findings from the ACTIVATE Randomized Pilot Trial. J Mens Health. 2022;18(9):191. doi: 10.31083/j.jomh1809191. Epub 2022 Sep 14.

  PMID: 36846742 DERIVED

MeSH Terms

Conditions

Weight Loss; Multiple Endocrine Neoplasia Type 1; Risk Reduction Behavior; Cardiovascular Diseases; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jessica G LaRose, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: January 20, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)