Investigating Mental and Physical Health Approaches for Supporting Men with Depression and Overweight or Obesity: A Feasibility Trial

Not Applicable

Recruiting

• Conditions: Depression; Overweight; Obesity; Mental Health - Depression; Diet and Nutrition - Obesity

• Registration Number: ACTRN12623001211651
• Lead Sponsor: Dr Myles Young

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-23
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Are 18 – 70-years-old
- Identifies as a man;
- Persistent low mood for at least two weeks (score of greater than or equal to 10 on the Patient Health Questionnaire – 9 item (PHQ-9))
- Are overweight (determined as a Body Mass Index (BMI) from 25 – 42 kg/m2);
- Have experienced a persistent low mood for at least two weeks;
- Own a computer, tablet or smartphone with internet access;
- Have a current email address and mobile phone number.

Exclusion Criteria

- Require intensive treatment or hospitalisation, as determined by the study psychologist (e.g., acute suicide risk);
- Have started psychological counselling or therapy in the past 4 weeks;
- Have started a new medication (or changed your dose in the past 4 weeks);
- Have had weight loss surgery in the past 12 months (or plan to during the study);
- Are unable to speak, read or understand English;
- Are participating (or plan to participate) in an alternative weight loss program;
- Are not willing to be randomly allocated into either study group;
- Have intentionally lost 5% or more of your body weight in the past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome: Recruitment capability<br>Measure: study database<br>Metric: number of eligible participants randomised<br>Indicator of feasibility: 40 participants recruited for trial[ At the conclusion of study];Outcome: participant satisfaction<br>Measure: Participants overall satisfaction with therapy using a single item likert scale developed for this study (1 = Poor, 2 = Fair, 3 = Average, 4 = Good, 5 = Excellent).<br>Metric: mean score<br>Indicator of feasibility: Mean score at least 4 / 5. Each study arm will be evaluated independently.[ primary time-point (3 months post-baseline)];Outcome: program usage (number of modules completed) Measure: average proportion of modules completed by participants. Data will be collected via the Articulate Reach platform analytics. Indicator of feasibility: at least 50% of modules completed on average (each study arm will be evaluated independently).<br>[ primary time-point (3 months post-baseline)]