Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903, United States
Location status: Recruiting
NCT Number: NCT05799846
The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are:
* Which of the three Internet-delivered weight loss programs results in the greatest weight loss? * How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? * What individual characteristics predict success in each arm? * What are the underlying mechanisms of each approach? * Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns).
Participants will:
* signed informed consent * complete a baseline assessment * be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE * complete a training workshop to learn arm-specific cognitive strategies * complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons * complete an assessment at 3 months (during treatment) * complete a refresher workshop on arm-specific cognitive strategies at 3 months * complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.
12-month online behavioral weight loss intervention
12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity
12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight
Time frame: 3 months after randomization
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Time frame: 6 months after randomization
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Time frame: 12 months after randomization
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Time frame: 18 months after randomization
Post-treatment weight change will be calculated as percent weight change observed at the 18 month assessment (6 months following treatment completion)
Time frame: 12 months after randomization
To address Secondary Aim 1, physical activity (PA) will be objectively-measured for 1 week at baseline, 3m, 12m, and 18m using ActigraphGT9X Link. Participants will be instructed to wear the accelerometer on their waist during all waking hours, exclusive of bathing and swimming, for 7 consecutive days. This monitor uses a validated triaxial accelerometer and proprietary data filtering technology to estimate free-living PA and sedentary behaviors. Accelerometer data will be processed and analyzed using Actigraph's ActiLife software. Data will be considered valid if the monitor was worn for more than 10 hours on more than 4 days (including one or more weekend day). Intensity will be assessed as average counts per minute (cpm) and previously validated cut points (Freedson et al., 1998) will be used to identify bout-related moderate-to-vigorous intensity PA (greater than or equal to 1952 cpm accumulated in bouts greater than or equal to 10 min) and sedentary time (less than 100 cpm).
Time frame: 12 months after randomization
Diet will be measured through 3, non-consecutive 24-hour diet recalls at baseline, 3m, 12m, and 18m. Recalls will be collected on two weekdays and one weekend at each time point with the first recall collected during the in-person assessment and the subsequent two recalls collected via phone. A trained interviewer will collect recalls using Nutrition Data Systems for Research (NDSR 2018; Nutrition Coordinating Center, University of Minnesota). NDSR uses a multipass method which provides participants multiple opportunities to recall each consumed food/beverage and reduces reporting biases. Given issues with use of dietary recalls to determine absolute energy intake, NDSR output will be used to examine changes in energy density and diet quality, as measured by the Healthy Eating Index, 2015 (HEI-2015). Component scores will highlight changes in intake of fruits and vegetables, whole grains, and lean proteins as well as calories from alcohol, added sugars and energy-dense snacks.
Time frame: 12 months after randomization
Intervention adherence will be assessed automatically via the study website during the entire 12-month iBWL treatment program. Outcome measures will include number of website number of intervention videos viewed.
Time frame: 12 months after randomization
Intervention adherence will be assessed automatically via the study website during the entire 12-month iBWL treatment program. Outcome measures will include number of website number of self-monitoring entries during the weight loss program.
The Miriam Hospital
Other
Adapting Episodic Future Thinking for Behavioral Weight Loss: Comparing Strategies and Characterizing Treatment Response
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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