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

NCT03040518 | Completed

• 1 other identifier: 14/185/09
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Behaviour change; Male obesity; SMS; Financial Incentive; Endowment incentive

Outcome Measures

Primary Outcomes (1)

• Decision whether to proceed to full RCT (Composite Measure)

  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

  12 months

Secondary Outcomes (10)

• Weight

  3, 6 and 12 months

• BMI

  3, 6 and 12 months

• Waist circumference

  3, 6 and 12 months

• Fruit and vegetable consumption

  6 and 12 months

• Physical activity

  6 and 12 months

Other Outcomes (7)

• Confidence in weight loss and weight loss maintenance

  3, 6 and 12 months

• Importance of weight loss

  3, 6 and 12 months

• Weight loss maintenance perceptions

  3, 6 and 12 months

Study Arms (3)

Narrative SMS

EXPERIMENTAL

Participants 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.

Behavioral: Narrative SMS

Narrative SMS and Endowment Incentive

EXPERIMENTAL

Participants 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.

Behavioral: Narrative SMS; Behavioral: Endowment Incentive

Waiting List Control Group

NO INTERVENTION

Participants will be on a waiting list for 12 months to receive the narrative SMS which will commence after 12 month outcome data has been collected. There will be no interim measurements or contacts by the research team. Men are therefore free to choose whether to try to lose weight during the 12 months. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer.

Interventions

Narrative SMS BEHAVIORAL

Narrative SMS have been defined as interactive life stories based around a range of characters (varying in age and socio-demographics) which can simulate the processes that make group-based interventions successful: humour, banter, peer support, facts about diet and PA and evidence based BCTs. The narrative form draws on real world learning from the film, television and games industry. When theorised, the narrative enables engagement with characters who convey the message of the intervention, and facilitate the viewer's empathy. Through creating an empathic bond with the character, users pay more attention to and become engaged and immersed within the story. This appears to lead to optimal learning and conceptualisation of the target information.

Narrative SMS; Narrative SMS and Endowment Incentive

Endowment Incentive BEHAVIORAL

All participants will be 'endowed' with an incentive at the start of the trial. It will be placed into a hypothetical personal account which is theirs for a year (no withdrawals). Participants will be able to secure money for verified weight loss at 3, 6, and 12 months.

Narrative SMS and Endowment Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Stirling: lead
• University of Aberdeen: collaborator
• Glasgow Caledonian University: collaborator
• University of Glasgow: collaborator
• University of Dundee: collaborator
• Queen's University, Belfast: collaborator
• University of New Brunswick: collaborator

Study Sites (2)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

NHS Forth Valley

Stirling, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33023501 DERIVED

• 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.

  PMID: 32102807 DERIVED

Related Links

• Main results paper in BMJ Open

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: February 2, 2017
• Study Start: March 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)