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Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)

ConditionObesity/therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Miriam Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body Mass Index between 25-45 kg/m2

Daily, home Internet access

Disqualifiers

Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months

Current or recent enrollment (<2 years) in a weight loss program

Presence of any medical condition for which exercise, weight loss, or dietary restriction is contraindicated

Recent weight loss (≥10 pounds within the past 6 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Automated online weight loss program

    Behavioral

    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.

  • Individual coaching

    Behavioral

    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.

  • Group-based, videoconference-delivered weight loss

    Behavioral

    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.

Treatment groups

490 Participants
are divided into 4 treatment groups
Group A: Automated online program + coachingExperimental treatment 2 interventions
Group B: Automated online program onlyExperimental treatment 1 intervention
Group C: Group videoconference program + coachingExperimental treatment 2 interventions
Group D: Group videoconference program onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors 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

Source ClinicalTrials.gov
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