NCT04628533

Brief Summary

This online pilot weight loss study will explore the feasibility of recruiting individuals to an established online behavioral weight loss program of varying duration (4 months vs. 6 months), We will compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention. Both groups will receive the same intervention; the only difference is the number of weeks the group will meet. Both groups will complete follow ups at 2, 4, 6, and 12 months (12 months after the study begins).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 2, 2020

Last Update Submit

November 12, 2020

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

  • Change in Weight from baseline to 2, 4, 6 and 12 months

    Weight loss at each follow-up will be calculated as % kg lost from baseline.

    2 months, 4 months, 6 months, 12 months

Secondary Outcomes (2)

  • Process measures: Attendance by subjects at weekly online meetings

    2,4,6 months

  • Process measures: Completion of weekly online treatment modules by subjects

    2, 4, 6 months

Study Arms (2)

Four Month Duration

EXPERIMENTAL

Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 16 weeks in a well-established behavioral weight loss program.

Behavioral: Four Month Duration Online Behavioral Weight Loss Program

Six Month Duration

ACTIVE COMPARATOR

Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 24 weeks in a well-established behavioral weight loss program.

Behavioral: Six Month Duration Online Behavioral Weight Loss Program

Interventions

Four Month Duration Online Behavioral Weight Loss ProgramBEHAVIORAL

Participants meet weekly on line with other group participants for 16 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.

Four Month Duration
Six Month Duration Online Behavioral Weight Loss ProgramBEHAVIORAL

Participants meet weekly on line with other group participants for 24 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.

Six Month Duration

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • BMI between 25-55
  • free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
  • not currently on medication that might affect weight loss
  • not currently pregnant or pregnant in the previous 6 months or currently breastfeeding
  • not enrolled in another weight reduction program
  • must have a computer (at home or work) with access to the Internet and a video camera
  • must have a smart phone (to allow use of step counting and dietary intake self-monitoring apps)
  • Only one member of a household will be eligible to participate
  • must successfully complete a self-monitoring diary of foods consumed for a week during screening for study eligibility
  • demonstrate the ability to access the website successfully (practice chat)
  • agree to be randomized to either group
  • must be willing to share access to self-monitoring information collected via the app MyFitnessPal, and Fitbit.com weight data collected via the digital smart scale (scale will be provided)

You may not qualify if:

  • have had a heart attack or a stroke in the past 6 months,
  • have ever had weight loss surgery,
  • have lost more than 10 pounds in the previous 6 months,
  • are currently taking medications for weight loss,
  • are required by their doctor to follow a special diet (other than a low fat diet)
  • have plans to move from the area in the upcoming 12 months
  • who have schedules that will make it likely that they will have difficulty attending the scheduled "chat" groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Behavioral Weight Management Program/Univ of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean R Harvey, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

  • Delia Smith West, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Dean, College of Agriculture and Life Sciences, Professor

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 13, 2020

Study Start

July 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

US(2)