Game of Stones: Helping men to lose weight

Type Article

Journal Article

Authors

Isrctn

Year of publication

2021

Publication/Journal

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN91974895

Volume

Issue

Pages

Abstract

INTERVENTION: Researchers will recruit men who want to lose weight from varied backgrounds. GP practices will send invitation letters and researchers will recruit men at community venues. After receiving written consent at the enrolment appointment, participants will be randomised using a secure remote web‐based system provided by the CHaRT CTU. The CHaRT randomisation service is independent of the data management and statistical team at CHaRT who will be undertaking the outcome data analysis. Randomisation will be stratified by trial centre. Men will be randomly allocated (1:1) to receive text messages to help them to lose weight for 12 months, or to be on the 12‐month waiting list to receive the text messages. Men will be weighed at 3, 6, 12, and 24 months and asked questions about their health, quality of life, well‐being, and experiences at 12 months. CONDITION: Obesity ; Nutritional, Metabolic, Endocrine ; Obesity PRIMARY OUTCOME: Weight loss is measured as % of baseline at 12 months measured using calibrated medical scales at baseline and 12 months SECONDARY OUTCOME: ; 1. Weight loss is measured in kg using calibrated medical scales at baseline, 3, 6, 12, and 24 months; 2. Mental well being is measured by the Warwick‐Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 12 months; 3. Health economic outcomes are measured by the EuroQol 5‐dimension (EQ‐5D) quality of life questionnaire and NHS Health care use questionnaires at baseline, 12, and 24 months; 4. Health behaviours (physical activity, smoking status, and alcohol intake) measured using a self‐report questionnaire at baseline and 12 months; 5. Weight management strategies used measured by self‐report questionnaire at baseline, 12, and 24 months; 6. Confidence in ability to lose and maintain weight loss is measured by self‐report questionnaire at baseline, 12, and 24 months; 7. Participant satisfaction is measured by self‐report questionnaire at 12 and 24 months; 8. Experience and behaviours is examined through qualitative data taken in interviews at 12 and 24 months; INCLUSION CRITERIA: 1. Men aged =18 years 2. BMI =30 kg/m² 3. Understand study information and able to give informed consent 4. Resident in and around Glasgow, Belfast, or Bristol