Clinical trial NCT03040518: Game of Stones: A Research Study That Texts Men to Help Them Lose Weight
Official title: Feasibility Study of How Best to Engage Obese Men in Narrative SMS (Short Message System) and Incentive Interventions for Weight Loss, to Inform a Future Effectiveness and Cost-effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Behaviour change
Male obesity
SMS
Financial Incentive
Endowment incentive
Lead sponsor: University of Stirling
Sponsor class: OTHER
Collaborators: name: University of Aberdeen
name: Glasgow Caledonian University
name: University of Glasgow
name: University of Dundee
name: Queen's University, Belfast
name: University of New Brunswick
First posted: 2017-02-02
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Decision whether to proceed to full RCT (Composite Measure)
timeFrame: 12 months
Secondary outcomes:
measure: Weight
timeFrame: 3, 6 and 12 months
measure: BMI
timeFrame: 3, 6 and 12 months
measure: Waist circumference
timeFrame: 3, 6 and 12 months
measure: Fruit and vegetable consumption
timeFrame: 6 and 12 months
measure: Physical activity
timeFrame: 6 and 12 months
measure: Smoking status
timeFrame: 6 and 12 months
measure: Alcohol consumption
timeFrame: 6 and 12 months
measure: EQ-5D-5L
timeFrame: 6 and 12 months
measure: Health Service Use
timeFrame: 6 and 12 months
measure: Wellbeing
timeFrame: 12 months
Other outcomes:
measure: Confidence in weight loss and weight loss maintenance
timeFrame: 3, 6 and 12 months
measure: Importance of weight loss
timeFrame: 3, 6 and 12 months
measure: Weight loss maintenance perceptions
timeFrame: 3, 6 and 12 months
measure: Weight loss techniques
timeFrame: 3, 6 and 12 months
measure: Weight maintenance focus
timeFrame: 3, 6 and 12 months
measure: Automaticity
timeFrame: 3, 6 and 12 months
measure: Self-regulation of eating behaviour
timeFrame: 3, 6 and 12 months
Locations:
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Stirling
country: United Kingdom
facility: NHS Forth Valley
Study officials:
References:
citation: McDonald MD, Dombrowski SU, Skinner R, Calveley E, Carroll P, Elders A, Gray CM, Grindle M, Harris FM, Jones C, Hoddinott P; Game of Stones team. Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial. BMC Med Res Methodol. 2020 Oct 6;20(1):249. doi: 10.1186/s12874-020-01136-2.
citation: Dombrowski SU, McDonald M, van der Pol M, Grindle M, Avenell A, Carroll P, Calveley E, Elders A, Glennie N, Gray CM, Harris FM, Hapca A, Jones C, Kee F, McKinley MC, Skinner R, Tod M, Hoddinott P. Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss. BMJ Open. 2020 Feb 25;10(2):e032653. doi: 10.1136/bmjopen-2019-032653.