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Trial record 79 of 661 for:    SMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040518
Recruitment Status : Unknown
Verified January 2017 by Stephan Dombrowski, University of Stirling.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
University of Aberdeen
Glasgow Caledonian University
University of Glasgow
University of Dundee
Queen's University, Belfast
Information provided by (Responsible Party):
Stephan Dombrowski, 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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Narrative SMS Behavioral: Endowment Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 1, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Narrative SMS

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 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.

Experimental: Narrative SMS and Endowment Incentive

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
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.

Behavioral: Endowment Incentive
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.

No Intervention: Waiting List Control Group

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.




Primary Outcome Measures :
  1. Decision whether to proceed to full RCT (Composite Measure) [ Time Frame: 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 :
  1. Weight [ Time Frame: 3, 6 and 12 months ]
  2. BMI [ Time Frame: 3, 6 and 12 months ]
  3. Waist circumference [ Time Frame: 3, 6 and 12 months ]
  4. Fruit and vegetable consumption [ Time Frame: 6 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

  5. Physical activity [ Time Frame: 6 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)


  6. Smoking status [ Time Frame: 6 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.

  7. Alcohol consumption [ Time Frame: 6 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

  8. EQ-5D-5L [ Time Frame: 6 and 12 months ]
    EQ-5D-5L

  9. Health Service Use [ Time Frame: 6 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


  10. Wellbeing [ Time Frame: 12 months ]
    Warwick and Edinburgh wellbeing questionnaire


Other Outcome Measures:
  1. Confidence in weight loss and weight loss maintenance [ Time Frame: 3, 6 and 12 months ]
    'How confident are you in your ability to lose weight? Scale from 1 (not confident) to 7 (very confident). 'How confident are you in your ability to keep lost weight off in the long term? Scale from 1 (not confident) to 7 (very confident).

  2. Importance of weight loss [ Time Frame: 3, 6 and 12 months ]
    'How important is losing weight for you at the moment?' Scale from 1 (not important) to 7 (very important).

  3. Weight loss maintenance perceptions [ Time Frame: 3, 6 and 12 months ]

    The below questions ask you about your weight loss in the last 3 months Items Items below rated strongly disagree, disagree, agree or strongly agree.

    In the last 3 months; I was; motivated to lose weight; tired most of the time; stressed most of the time; hungry most of the time; having to think a lot about my weight loss plan; following my weight loss plan without having to think much about it; satisfied with the results of my weight loss; enjoyed following my weight loss plan; doing things which conflicted with my weight loss plan; doing things which helped me with my weight loss plan; supported by my friends and family to stick to my weight loss plan; in places and situations that made it difficult to follow my weight loss plan.


  4. Weight loss techniques [ Time Frame: 3, 6 and 12 months ]

    Have you done any of the following over the last 3 months?' Choose from; not at all; 1-2 times a month; about weekly or every day or most days.

    Tried to limit what you eat or drink to try to lose weight?; done an exercise workout (including video/ DVD workouts) at home?; attended a commercial weight loss programme (e.g. Weight Watchers); attended a gym, leisure centre or local sport facility to swim or take part in other psychical activity sessions?, attended a weight-reduction clinic at your GP surgery or another NHS setting?


  5. Weight maintenance focus [ Time Frame: 3, 6 and 12 months ]

    If my weight stays the same for the next 3 months I would consider it a success, even if I don't lose any If my weight stays the same for the next 3 months I would be happy, even if I don't lose any. Scale from 1 (strongly disagree) to 7 (strongly agree).

    'I am trying to maintain my weight loss at the moment rather than trying to lose more weight' Scale from 1 (strongly disagree) to 7 (strongly agree).


  6. Automaticity [ Time Frame: 3, 6 and 12 months ]
    'Eating fruits and vegetables is something I do automatically' Scale from 1 (strongly disagree) to 7 (strongly agree) 'Being psychically active is something I do automatically' Scale from 1 (strongly disagree) to 7 (strongly agree)

  7. Self-regulation of eating behaviour [ Time Frame: 3, 6 and 12 months ]
    Self-Regulation of Eating Behaviour Questionnaire (SREBQ - Kliemann et all., 2016; doi: 10.1186/s12966-016-0414-6)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040518


Contacts
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Contact: Stephan U Dombrowski, PhD s.u.dombrowski@stir.ac.uk
Contact: Pat M Hoddinott, PhD p.m.hoddinott@stir.ac.uk

Locations
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United Kingdom
NHS Forth Valley Not yet recruiting
Forth Valley, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow and Clyde, United Kingdom
Sponsors and Collaborators
University of Stirling
University of Aberdeen
Glasgow Caledonian University
University of Glasgow
University of Dundee
Queen's University, Belfast

Additional Information:
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Responsible Party: Stephan Dombrowski, Senior Lecturer, University of Stirling
ClinicalTrials.gov Identifier: NCT03040518     History of Changes
Other Study ID Numbers: 14/185/09
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephan Dombrowski, University of Stirling:
Behaviour change
Male obesity
SMS
Financial Incentive
Endowment incentive
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms