Overweight and Obesity Clinical Trial
— SMART 2Official title:
SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Verified date | March 2024 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.
Status | Completed |
Enrollment | 638 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Age 18 to 35 years - Intending to be available for a 24 month intervention - Affiliated with either University of California, San Diego (UCSD), San Diego State University (SDSU), or California State University, San Marcos (CSUSM) as a student, faculty, or staff - Willing and able to use social media - Willing and able to use a smartphone and text messaging - Willing and able to use the wearable, scale, and corresponding app - Willing and able to attend measurement visits over the 2 year intervention - Willing and able to engage in moderate to vigorous physical activity - Overweight or obese, but not severely obese (25 >= BMI < 40 kg/m2) Exclusion Criteria: - Any comorbidities of obesity that require a clinical referral including eating disorders, pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes - Psychiatric or medical conditions that prohibit compliance with the study protocol - Had a cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months - Currently being treated for a malignancy (other than non-melanoma skin cancer) - Currently being treated and/or have an eating disorder - Planning to have a weight loss surgery in the next 24 months (e.g., liposuction, lap band, gastric bypass) - Pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, or actively planning pregnancy within the next 24 months - Prescribed physical activity and/or dietary changes - Prescribed medications that alter weight - Enrolled in or planning to enroll in a weight loss program during the study period - Lost more than 15 pounds within the past 3 months |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | National Institutes of Health (NIH), Small Steps Labs, LLC |
United States,
Godino JG, Merchant G, Norman GJ, Donohue MC, Marshall SJ, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Raab F, Fogg BJ, Robinson TN, Patrick K. Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):747-755. doi: 10.1016/S2213-8587(16)30105-X. Epub 2016 Jul 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Smoking & Marijuana Use | Assessed using modified items from the Customary Drinking and Drug Use Record. Participants will respond to 26 items related to their smoking and marijuana use over the past 6 months. | Baseline, 24 months | |
Other | Alcohol Use | Assessed using modified items from the Customary Drinking and Drug Use Record. Participants will respond to 10 items related to their alcohol use over the past 6 months. | Baseline, 24 months | |
Primary | Change in weight | Objectively measured weight in kilograms. | Baseline, 24 months | |
Secondary | Change in Body Mass Index | Weight and height will be combined to report BMI in kg/m^2. | Baseline, 24 months | |
Secondary | Percent weight change | Percent change in weight from baseline. | Baseline, 24 months | |
Secondary | Percentage of participants who lost at least 3% of their weight from baseline | Percentage of participants who lost at least 3% of their weight from baseline. | Baseline, 24 months | |
Secondary | Percentage of participants who lost at least 5% of their weight from baseline | Percentage of participants who lost at least 5% of their weight from baseline. | Baseline, 24 months | |
Secondary | Change in waist circumference | Objectively measured in centimeters. | Baseline, 24 months | |
Secondary | Change in waist-to-hip ratio | Waist and hip circumference will be combined to report waist-to-hip ratio in cm/cm. | Baseline, 24 months | |
Secondary | Change in body composition | Total body and regional (arms, legs, trunk, and abdomen) body composition (fat mass, including an estimate of visceral adipose tissue, and lean mass) measured with Dual-energy X-ray Absorptiometry (DXA). | Baseline, 24 months | |
Secondary | Change in bone mineral density | Bone mineral density of anterior-posterior spine (L1 - L4), hip, forearm, and total body measured with Dual-energy X-ray Absorptiometry (DXA). | Baseline, 24 months | |
Secondary | Change in systolic blood pressure | Systolic blood pressure in mmHg. | Baseline, 24 months | |
Secondary | Change in diastolic blood pressure | Diastolic blood pressure in mmHg. | Baseline, 24 months | |
Secondary | Change in cardiorespiratory fitness | Three-minute step test. | Baseline, 24 months | |
Secondary | Change in flexibility | Sit and reach test. | Baseline, 24 months | |
Secondary | Change in grip strength | Grip strength of the right and left hands in kilograms with a dynamometer. | Baseline, 24 months | |
Secondary | Physical activity | Measured using Fitbit. | Through study completion, up to 24 months | |
Secondary | Physical activity | Measured using a waist-worn tri-axial accelerometer. | For 7 days, at 24 months | |
Secondary | Change in physical activity | Assessed through self-report using the Global Physical Activity Questionnaire. The questionnaire is comprised of 16 questions related to physical activity in three settings that include activity at work, travel to and from places, and recreational activities, in addition to sedentary behavior. Metabolic Equivalent (MET) values are assigned to time variables according to intensity of activity, moderate or vigorous, reported in each of the settings. MET values are then used to calculate total physical activity. | Baseline, 24 months | |
Secondary | Sleep | Measured using Fitbit. | Through study completion, up to 24 months | |
Secondary | Change in sleep | Assessed through self-report using an 8 item self-report questionnaire. Participants respond to questions related to sleep duration and how often they have difficulty falling asleep and staying awake, do not get enough rest. | Baseline, 24 months | |
Secondary | Resting heart rate | Measured using Fitbit. | Through study completion, up to 24 months | |
Secondary | Change in resting heart rate | Measured by research assistant. | Baseline, 24 months | |
Secondary | Sedentary Behavior | Measured using Fitbit. | Through study completion, up to 24 months | |
Secondary | Sedentary Behavior | Measured using a waist-worn tri-axial accelerometer. | For 7 days, at 24 months | |
Secondary | Change in sedentary Behavior | Assessed through self-report using 5 items from the Canadian Fitness Survey and 10 items from the Past-day Adults' Sedentary Time Questionnaire. Participants respond to items from the Canadian Fitness Survey related to how much time participants spend doing sedentary activities on a 5-point response scale ranging from "Almost all of the time" to "Almost none of the time". Participants respond to items from the Past-day Adults' Sedentary Time Questionnaire related to how much time spent sitting while doing activities including working, transportation, etc. using 2 digit entry for hours and minutes. For all items, less time reported doing sedentary activities or sitting represents less sedentary behavior. | Baseline, 24 months | |
Secondary | Diet History Questionnaire III | The Diet History Questionnaire III contains 135 food and beverage items and 26 dietary supplement items to assess diet consumption for past month. The questionnaire includes additional embedded questions for some items to assess frequency and portion size. | Baseline, 24 months | |
Secondary | Weight Management Practices | Assessed through self-report using a 3-item questionnaire. Participants respond to items related to which behaviors they have engaged in in the past 30 days to lose weight, how often they weigh themselves using a 6 point response scale ranging from "Never" to "More than once a day", and whether they have access to a scale at home. | Baseline, 24 months | |
Secondary | Strategies for Weight Management Questionnaire | Strategies for Weight Management Questionnaire consists of 35 items that assess how often participants use of behavioral strategies for reducing energy intake and increasing energy expenditure on a 5-point response scale ranging from "Never or hardly ever" to "Always or almost always". Values which indicate a higher frequency of strategies, "Much of the time" and "Always or almost always", show improved weight management. | Baseline, 24 months | |
Secondary | Assessment of Eating Behaviors | Assessment of Eating Behaviors survey consists of 8 items that assess sugar sweetened beverage consumption and frequency of eating away from home on a 9-point response scale ranging from "Never or rarely" to "3 or more times per day". | Baseline, 24 months | |
Secondary | Daily Meal Patterns | Assessed through self-report using a 7-item questionnaire. Participants respond to items related to how often they eat meals and snacks in a typical week using a 5-point response scale ranging from "0 times" to "7 times". | Baseline, 24 months | |
Secondary | Healthy Eating: Change Strategies | Healthy Eating: Change Strategies survey consists of 15-items that assess how often participants engage in strategies that help them change their dietary habits in the past month using a 5-point response scale ranging from "Never" to "Many times". | Baseline, 24 months | |
Secondary | Physical Activity: Change Strategies | Physical Activity: Change Strategies survey consists of 15-items that assess how often participants engage in strategies that help them change their physical activity in the past month using a 5-point response scale ranging from "Never" to "Many times". | Baseline, 24 months | |
Secondary | Physical Activity Neighborhood Environment | Physical Activity Neighborhood Environment survey consists of 17-items that assess the environmental factors for walking and bicycling in various neighborhoods. Higher values from the scale indicate greater environmental support for physical activity. | Baseline, 24 months | |
Secondary | Social Support for Healthy Eating Habits | Social Support for Diet survey consists of 10-items that assess perceived social support specific to health-related eating behaviors from family and friends, respectively. Each item uses a 8-point response scale that includes "does not apply" and ranges from "none" to "very often". | Baseline, 24 months | |
Secondary | Social Support for Physical Activity | Assessed using the Physical Activity and Social Support Scale which consists of 20-items scale based in five forms of social support - companionship, emotional, instrumental, informational, and validation for physical activity. Participants respond to items on a 7-point Likert scale ranging from "never" to "always", or "not applicable". | Baseline, 24 months | |
Secondary | Depression | Assessed using the Center for Epidemiologic Studies depression scale which consists of 10-items. Participants respond to items related to how they feel and behave on a 5-point response scale ranging from "Rarely or none of the time" to "All of the time". A score equal to or above 10 is considered depressed. | Baseline, 24 months | |
Secondary | Anxiety | Assessed using the short-form of the state scale of the Spielberger State Trait Anxiety Inventory which consists of 6 items. Participants respond to items related to how they feel on a 4-point response scale ranging from "Not at all" to "Very much". | Baseline, 24 months | |
Secondary | Self-esteem | Assessed using the Rosenberg Self-esteem Scale which consists of 10-items. Participants respond to items related to items related to global self-worth on a 4-point Likert scale ranging from "strongly agree" to "strongly disagree". Higher scores indicate higher self-esteem. | Baseline, 24 months | |
Secondary | Quality of Well-being | Assessed using the Quality of Well-being survey, self-administered version which consists of 71 items. Participants respond to items related to health status and overall well-being over the previous 3 days. Scores are translated to quality-adjusted life years. | Baseline, 24 months | |
Secondary | Body Image | Assessed using the Eating Disorder Inventory, Body Dissatisfaction sub scale which consists of 9-items. Participants respond to items related to their body image on a 6-point response scale ranging from "Never" to "Always". | Baseline, 24 months |
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