Cognitive Strategies for Weight Loss
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Miriam Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work.
Disqualifiers
Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Behavioral Weight Loss Intervention
Behavioral12-month online behavioral weight loss intervention
PREVENT Behavioral Weight Loss Intervention
Behavioral12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity
PROMOTE Behavioral Weight Loss Intervention
Behavioral12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: STANDARD BehavioralActive comparator 1 intervention
Group B: PREVENTExperimental treatment 1 intervention
Group C: PROMOTEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent Weight Change at 3 months
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Time frame
3 months after randomization2
Percent Weight Change at 6 months
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Time frame
6 months after randomization3
Percent Weight Change at 12 months
Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Time frame
12 months after randomization4
Percent Weight Change Post-Treatment
Post-treatment weight change will be calculated as percent weight change observed at the 18 month assessment (6 months following treatment completion)
Time frame
18 months after randomizationSecondary outcomes
1
Change in Actigraph-measured Physical Activity (PA)
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 randomization2
Change in Dietary Recall
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 randomization3
Intervention Adherence - lessons viewed
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 randomization4
Intervention Adherence - self-monitoring
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.
Time frame
12 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Miriam Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Brown University
Collaborator
University of Minnesota
Collaborator
Source ClinicalTrials.gov