Clinical trial · Interventional
A Novel Approach to Reducing Adiposity Among Young Men
NCT04267263CI-TRIAL-00052886completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Lifestyle Risk Reduction | — | UNRESOLVED | — |
| Men | Multiple Endocrine Neoplasia | ALIAS | 0.90 |
| Obesity | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-guided lifestyle intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Delayed Treatment Control group
- description
- Participants will receive the treatment after completion of the 3-month follow-up assessment
- type
- EXPERIMENTAL
- label
- Lifestyle group
- description
- Participants will receive the treatment immediately
- interventionNames
- Behavioral: Self-guided lifestyle intervention
Primary outcomes (1)
- measure
- Percent weight lost
- timeFrame
- 3 months
- description
- Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight \*100
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. self-identify as a man 2. 18-35 years old 3. BMI 25-45kg/m2 4. Live in North America Exclusion Criteria: 1. an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension) 2. a diagnosis of Type 1 or Type 2 diabetes 3. 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 4. currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery 5. change in medication(s) within the last 3 months that could influence weight (e.g., steroids) 6. have lost \> 5% body weight within the last 3 months 7. report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months 8. report hospitalization for a psychiatric condition within the last year 9. report high alcohol intake (AUDIT score \> 16). 10. are not able to speak and read English 11. do not possess a mobile device or are unwilling to use it to receive study text messages 12. 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).
References
Publications (2)
- DERIVEDReading 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
- DERIVEDReading 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