SMART: A Social and Mobile Weight Control Program for Young Adults

Study Overview
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Brief Summary
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The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control trial designed to evaluate the hypothesis that weight status at 24 months will be significantly better for the SMART intervention recipients than for those who receive the comparison condition.

Detailed Description
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The focus of the SMART study is to develop an intervention to promote weight loss in overweight or obese young adults. The investigators will recruit college and university students to evaluate the effects of SMART on weight status and other metabolic, behavioral and psychosocial outcomes up to and including 24 months. The Primary aim of the study is to evaluate between condition differences in weight status at 24 months. Secondary aims will assess the impact of the SMART intervention on: Diet, physical activity, sedentary behaviors, quality of life and depression at 6, 12, 18 and 24 months; Anthropometric measures (BP, waist circumference) at 6, 12, 18 and 24 months; Differences in weight status at 6, 18 and 24 months; Level of satisfaction and amount of use of the intervention components. These aims will be applied to overweight/obese young adults. Among overweight/obese young adults, the investigators will determine whether SMART produces weight loss.

Official Title
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SMART: A Social and Mobile Weight Control Program for Young Adults

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Social/mobile weight loss promotion intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 35 years Intending to be available for a 24 month intervention Full-time student enrollment at one of the designated San Diego college or university campuses: UCSD, SDSU, and CSU San Marcos Facebook user or willingness to begin using Facebook Owns personal computer Owns mobile phone and uses text messaging Willing to attend required research measurement visits in San Diego over the 2 year RCT Participants must meet overweight and obesity criteria: 25 < BMI <35 kg/m2 English-speaking Able to ambulate unassisted Exclusion Criteria: Those unable to provide informed consent Those with a BMI of <25 kg/m2 or >35 kg/m2 Those who have a household member on the study staff Those with any comorbidities of obesity who require immediate sub-specialist referral including pseudo-tumor cerebri, sleep apnea/hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes Cardiovascular event within the last 6 months Systolic BP at screening of >160 mmHg OR diastolic BP > 100 mmHg Current treatment for malignancy other than non-melanoma skin cancer Psychiatric or medical condition that prohibit compliance with study protocol, prescribed dietary changes and/or moderate physical activity Current treatment for eating disorder Taking medications that alter weight Regular use of systemic steroids Currently pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months or intending to get pregnant over the next two years Enrolled in or planning to enroll in another weight loss program Past or planned (within the next 24 months) weight loss surgery Current participation in a commercial weight loss program Investigator discretion Non-English speaking Not able to ambulate unassisted

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social/Mobile Intervention<br>Theory-based intervention to promote weight loss utilizing web, mobile phone and social media. | Behavioral: Social/mobile weight loss promotion intervention.<br>* Social/mobile intervention for weight loss promotion, compared to control group.<br>|
| No Intervention: Control<br>Participants randomized to this group will have access to usual care health information via the SMART study website. This arm will be compared to our intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight status |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight Loss, Healthy Lifestyle, Social, Mobile, Facebook, Text Messages