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Game of Stones: A Research Study That Texts Men to Help Them Lose Weight

Not Applicable
Completed
Conditions
Obesity
Interventions
Behavioral: Narrative SMS
Behavioral: Endowment Incentive
Registration Number
NCT03040518
Lead Sponsor
University of Stirling
Brief Summary

In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes. This study looks at whether two interventions which show promise can help obese men lose weight and keep it off.

INTERVENTION 1: Sending text messages to a mobile phone. These will be written as though they come from other men who are also losing weight and include 'how to do it' diet and physical activity tips, combined with friendly humour and support.

INTERVENTION 2: The same texts plus promising men money at the start contingent on weight loss achievement. The money will vary over a year according to whether weight targets are met. This is called an endowment incentive and is based on research showing that modest payment helps people change their diet and physical activity. At the 3, 6 and 12 month weighing appointments, men will have the option of continuing with the original weight loss targets of 5%, 10% and 10% or setting lower targets of 5% of body weight at 6 months and 5% at 12 months. This is to maintain motivation and hope for men who do not meet the more ambitious weight loss targets.

This study examines if the texts work better with incentives than alone. Both interventions are delivered from a computer and have potential to reach large numbers, including men who don't use health services. This work is done together with obese men and a charity for men to help us find the best ways to deliver the interventions to as many men as possible, including men in difficult life situations.

This study will examine whether it is acceptable and feasible to randomise obese men to three groups: texts only; texts and incentive; or to a 'control group' who wait a year and then get the texts for 3 months. The feasibility of recruiting 105 obese men from two regions of Scotland will be assessed. Half of the men will get an invitation letter from their GP. The other half will be approached in the community, given information about the study and invited to take part. Men can take part if their waist circumference is 40 inches and more or their Body Mass Index is 30 or higher. The study examines how long it takes to find 105 obese men who want to take part, how many come back to suitable venues at 3, 6 and 12 months to get weighed and answer questions about their quality of life, lifestyle and motivation. At the end participants will report about their experiences of weight loss and of being in the study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
105
Inclusion Criteria
  • Obese adult men aged 18 or over with and without known health conditions, who do or do not access GP services. Obesity is defined as a BMI equal to or over 30 and/or a waist circumference measurement equal to or above 40 inches (102cm)
Exclusion Criteria
  • Insufficient English language for SMS intervention; no mobile phone access.
  • Planning to move out of the area within 12 months.
  • Current or recent participation in a research weight loss intervention study (in the last 3 months).
  • For GP recruitment: severe medical, terminal or psychiatric illness (patient or close family member)
  • Impaired cognitive function that would limit understanding of study information and SMS messages.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Narrative SMSNarrative SMSParticipants will receive narrative SMS for 12 months. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer.
Narrative SMS and Endowment IncentiveNarrative SMSParticipants will receive narrative SMS for 12 months. In addition, they will receive an endowment incentive for verified weight loss. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer.
Narrative SMS and Endowment IncentiveEndowment IncentiveParticipants will receive narrative SMS for 12 months. In addition, they will receive an endowment incentive for verified weight loss. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer.
Primary Outcome Measures
NameTimeMethod
Decision whether to proceed to full RCT (Composite Measure)12 months

A decision whether to proceed to a full effectiveness and cost-effectiveness RCT for the SMS intervention, with or without an incentive, compared to a waiting list control. This will be based on the progression criteria:

1. Acceptability of the intervention and the control group (willingness to be randomised, intervention engagement, participant retention, qualitative views)

2. Feasibility of recruiting 105 men in 4 months

3. 12 month outcomes on at least 72 % of men randomised per group

4. Evidence of mean weight loss of at least 3% of baseline weight at 12 months in any intervention group

An Independent Trial Steering Committee will decide whether the findings support a two or three arm trial or not

Secondary Outcome Measures
NameTimeMethod
Waist circumference3, 6 and 12 months
Smoking status6 and 12 months

'Do you currently smoke or have you ever smoked?' Choose from; Yes, I currently smoke every day; Yes, I currently smoke, but not every day; Yes, I used to smoke but have quit or No, I have never smoked.

Wellbeing12 months

Warwick and Edinburgh wellbeing questionnaire

Fruit and vegetable consumption6 and 12 months

"How many portions of fruit and vegetables (including pulses, salad, vegetables, fruit juices and fresh, dried and canned fruit) did you eat yesterday?" Answered on a scale of none to 7 or more

Physical activity6 and 12 months

International Physical Activity Questionnaire items:

'During the last 7 days, on how many days do you do moderate physical activities like carrying light loads, bicycling at a regular pace or walking?' Answered on a scale of days per week (none to 7) 'During the last 7 days, how much time did you spend sitting?' On a week day? (Answered in hours and minutes) On a weekend day? (Answered in hours and minutes)

Alcohol consumption6 and 12 months

'During the last month, how many days did you usually have any kind of drink containing alcohol?' Choose from: Everyday; 5 to 6 times a week; 3 to 4 times a week; twice a week; once a week; 2 to 3 times a month; once a month or never

BMI3, 6 and 12 months
Health Service Use6 and 12 months

Over the LAST 3 MONTHS, have you used any of the following NHS Services? Choose from: Your GP or another GP Nurse Doctor or nurse in an emergency department (causality/ A\&E) Outpatient appointments Inpatient stay

Yes/No

EQ-5D-5L6 and 12 months

EQ-5D-5L

Weight3, 6 and 12 months

Trial Locations

Locations (2)

NHS Greater Glasgow and Clyde

🇬🇧

Glasgow, United Kingdom

NHS Forth Valley

🇬🇧

Stirling, United Kingdom

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