An interventional study of Automated online weight loss program and Individual coaching in Obesity/therapy, sponsored by The Miriam Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment
The purpose of this trial is to compare two delivery formats for weight loss (automated online program vs. group-based videoconference program) and to examine the added effect of individual coaching (vs. no coaching) for individuals with overweight or obesity. All participants enrolled in this study will receive a 12-month behavioral weight loss program (varying in delivery format and individual support), and will be provided with weight loss, calorie intake, and exercise goals. Assessments will occur at baseline, 6 (mid-treatment), 12 (post-treatment), and 18 months (following 6 months of no intervention). We will also seek to determine which combination of intervention approaches works best for whom and develop algorithms which can be used to refer patients into remote programs in clinical settings or future trials.
Participants will be randomized at baseline to one of four weight loss intervention conditions: 1) automated program + coaching, 2) automated program + no coaching, 3) group videoconference program + coaching, and 4) group videoconference program + no coaching. All participants will be provided with weekly goals, instructed to self-monitor diet, exercise, and weight daily, and provided with feedback based upon these data. Those receiving the online program will also be instructed to view video lessons (24 in total, 10-15 min each) which focus on behavioral strategies for changing diet and exercise. Individuals randomized to the videoconference program will participate in 24 group sessions (1 hour each) designed to mimic in-person treatment and allow for participant interaction via large and small group discussions. The content across conditions will be similar and the lessons will be provided weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. Those receiving coaching will have individual, monthly meetings with a coach via videoconference (\~15 min each). Coaching sessions will focus on individual barriers, problem solving, goal setting, and fostering support and accountability.
The primary aim of this study is to examine the effects of delivery format (automated online vs. videoconference) and coaching (individualized vs. none) on weight loss at 12 months. Secondary aims will examine the effects of delivery format and coaching on intervention engagement (e.g., frequency of self-monitoring), psychosocial outcomes (e.g., perceived support, self-efficacy, and motivation), 18-month weight loss, and the cost per kilogram of weight loss (to examine whether the addition of human support is cost-effective). Two algorithms will also be developed to predict which treatment type should be recommended to whom, using only baseline characteristics: 1) a 'widely-applicable' algorithm which will use metrics common to electronic medical records (sex, BMI, age, race, ethnicity), and 2) a 'more comprehensive' algorithm which will further include additional baseline characteristics (e.g., education, household income, health literacy, group preference, etc).
1,767 studies on the registry are indexed under Weight Loss; 278 are open to participants now.
This study's planned enrollment of 490 is above the median of 73 across 1,497 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet plus monthly, individual coaching sessions delivered via videoconference.
Behavioral: Automated online weight loss program · Behavioral: Individual coaching
Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet.
Behavioral: Automated online weight loss program
Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference plus monthly, individual coaching sessions delivered via videoconference.
Behavioral: Individual coaching · Behavioral: Group-based, videoconference-delivered weight loss
Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference.
Behavioral: Group-based, videoconference-delivered weight loss
Participants receiving this program are given a daily calorie intake goal of 1200-1800 kcal/day based upon their starting weight and a moderate-intensity aerobic exercise (e.g., walking) goal which progresses to 250 min/week. They are instructed to self-monitor body weight, calorie intake, and exercise minutes daily over 12 months, and are provided with a smart scale for electronic transmission of weight data. Computer-generated, personalized feedback is based upon self-monitoring data, and provided weekly during months 1-3, twice per month during months 4-6, and monthly thereafter. Participants are also instructed to view a new multi-media video lesson weekly during months 1-3, 2x/month during months 4-6, and monthly thereafter (24 lessons in total). These videos are 10-15 minutes in duration and are intended to teach behavioral principles for losing weight, healthy eating, and exercise.
Participants will receive monthly, one-on-one coaching sessions (12 in total) throughout the 12-month intervention period. Coaching sessions will be conducted via videoconference and the initial coaching session will be approximately 30 minutes and all remaining sessions will be approximately 15 minutes. The structure of the coaching sessions will be similar across participants, but the content will be tailored to the individual. Coaches will use goal setting, problem solving, and motivational interviewing to help facilitate adherence and achievement of weight loss program goals.
Participants receiving this program will be instructed to attend interactive group videoconference sessions (60 minutes each) focused on behavioral strategies for changing diet and exercise to promote weight loss. Classes will be weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. These classes are designed to allow participants to interact with, support, and learn from one another. Participants are also given a daily calorie intake goal of 1200-1800 kcal/day based upon their starting weight and a moderate-intensity aerobic exercise (e.g., walking) goal which progresses to 250 min/week. They are instructed to self-monitor body weight, calorie intake, and exercise minutes daily over 12 months, and are provided with a smart scale for electronic transmission of weight data. Semi-automated, personalized feedback, based on self-monitoring data, is provided by the group instructor at the same frequency as group sessions are held.
Percent weight change
Weight change will be assessed via smart scales using weight at baseline and 12 months and calculated as follows: (\[12-month weight minus baseline weight\] / baseline weight \* 100).
Time frame: 12 months
Change in perceived support
Perceived support will be measured via the Important Others Questionnaire. Scores on this questionnaire range from 12 to 84 with higher scores indicating a greater perception of support from important others. Change in perceived support will be calculated as follows: 12-month perceived support minus baseline perceived support.
Time frame: 12 months
Cost per kilogram of weight loss
The cost per participant to deliver the intervention will be calculated and divided by the average weight change (in kilograms) from baseline to 12 months.
Time frame: 12 months
Percent weight change
Weight change will be assessed via smart scales using weight at baseline and 18 months and calculated as follows (\[18 month weight minus baseline weight\] / baseline weight \* 100).
Time frame: 18 months
Frequency of self-monitoring weight
The number of days that a participant stepped on the scale over the 12-month intervention period will be calculated.
Time frame: 12 months
Self-monitoring of calorie intake
The number of days that a participant reported their calorie intake over the 12-month intervention period will be calculated.
Time frame: 12 months
Change in self-efficacy for diet
Self-efficacy for diet will be measured via the Weight Efficacy Lifestyle Questionnaire. Scores range from 0 to 80, with higher scores indicating greater self-efficacy. Change in self-efficacy for diet will be calculated as 12-month score minus the baseline score.
Time frame: 12 months
Self-efficacy for exercise
Self-efficacy for exercise will be measured via the Self-Efficacy for Exercise Scale. Scores range from 0 to 90 with higher scores indicating greater self-efficacy. Change in self-efficacy for exercise will be calculated as the 12-month score minus the baseline score.
Time frame: 12 months
Change in autonmous motivation
Autonomous motivation will be measured via the Treatment Self-Regulation Questionnaire for Weight Management (autonomous motivation subscale). Scores range from 6 to 42 and higher scores indicate more autonomous motivation. Change in motivation will be calculated as the 12-month score minus the baseline score.
Time frame: 12 months
Change in controlled motivation
Controlled motivation will be measured via the Treatment Self-Regulation Questionnaire for Weight Management (controlled motivation subscale). Scores range from 6 to 42 and higher scores indicate more controlled motivation. Change in motivation will be calculated as the 12-month score minus the baseline score.
Time frame: 12 months
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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