A Randomized Controlled Trial of the Effect of a Text Message Intervention on Obesity Improvement in Adult Male Workers Under Age 40 (Pilot Study)

UMIN ID: UMIN000054203

Registered date:24/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: obesity
• Date of first enrollment: 2024/04/30
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention group - at the start, knowledge about obesity and lifestyle modification is provided by brochures; health guidance for obesity modification is provided by text message delivery three times a week for three months. The intervention is one-way with text message delivery.
Control group - at the start, knowledge about obesity and the significance of lifestyle modification is provided by brochures.

Outcome(s)

• Primary Outcome: Evaluate the effectiveness of the intervention. Percentage of weight loss achieved at the time of evaluation from baseline. Weight loss attainment should be targeted at 3% of body weight.
• Secondary Outcome: 1)Baseline, 3 months later: BMI, abdominal circumference, Weight Efficacy Life-Style Questionnaire, New General Self-Efficacy Scale Japanese version : NGSE-J, Stages of Change regarding lifestyle improvement initiatives Change 2)Three months later: intervention group only. Study subjects are asked to rate their satisfaction, utilisation and recommendation to others on a five-point scale and an open-ended questionnaire. Frequency, timing and duration of message delivery will be assessed. 3) At baseline, one month, two months and three months Evaluate the SMS reachability rate and URL click rate from the SMS platform and the number of accesses from the research website.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 40years-old
• Gender: Male
• Exclude criteria: 1) Working night shifts. 2) Cannot communicate in Japanese. 3) Are receiving regular medical care or have a pre-existing medical condition that prevents them from eating a healthy diet or participating in physical activity and are in hospital.

Related Information

• Primary Sponsor: Mejiro University
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology