- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293055
Phone Coaching for Weight Loss Maintenance
December 19, 2024 updated by: Jessica Unick, The Miriam Hospital
Examination of Phone Coaching as a Weight Loss Maintenance Strategy
The purpose of this study was to examine whether 4 consecutive weeks of phone coaching aids in recovery from weight regain during weight loss maintenance.
Individuals who previously achieved and maintained a >=5% weight loss in a 1-year behavioral weight loss program were provided with a low-intensity maintenance intervention (monthly newsletters and smart scale).
At baseline, participants were randomized to the coaching group or the control group (no coaching).
If participants regained >1.5% of their weight, randomization was "triggered."
At this point, participants randomized to the coaching condition received 4 brief weekly coaching calls; participants randomized to the control condition received no additional intervention contact.
Short-term and long-term weight change was assessed and compared between treatment groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- The Miriam Hospital's Weight Control and Diabetes Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 72 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-72 years of age
- Recent completion of a 1-year behavioral weight loss program
- Achievement of >=5% weight loss at the end of the 1-year weight loss program
Exclusion Criteria:
- Not currently enrolled in another weight management program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Maintenance program+possibility of phone coaching
All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term.
Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff.
Some participants randomized to this condition will also receive 4 consecutive weeks of phone coaching at some point over the 1-year intervention period (this is determined by a weight-based algorithm).
|
1-year weight loss maintenance program, consisting of monthly newsletters
Some individuals will receive 4 consecutive weeks of phone coaching.
The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration.
Coaches will help support participants in their weight loss maintenance efforts.
Once coaching calls are completed, the participant will not have any other contact with their coach.
|
|
Active Comparator: Maintenance program only
All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term.
Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff.
No participants in this condition will receive phone coaching.
|
1-year weight loss maintenance program, consisting of monthly newsletters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change in Body Weight From Baseline to Month 12
Time Frame: Baseline and Month 12
|
Baseline and Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Weight Change Over the Coaching Period
Time Frame: Trigger date and 40 days post-trigger date
|
The 'coaching period' weight change was calculated by subtracting the 'trigger date' weight (i.e., the weight measurement from the smart scale on the day the participant achieved the trigger threshold, which was defined as the final day in a series of 4 days >1.5% or the final day in which the previous 7 days averaged >1.5%) from the smart scale weight 40 days following the 'trigger date'.
Percent weight change was then calculated by taking the 'coaching period weight change' and dividing it by the 'trigger date weight' and multiplying by 100.
Therefore, a negative number indicates weight loss and a positive number indicates weight gain over the 40-day coaching period.
|
Trigger date and 40 days post-trigger date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jessica L Unick, PhD, The Miriam Hospital's Weight Control and Diabetes Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2020
Primary Completion (Actual)
August 23, 2023
Study Completion (Actual)
August 23, 2023
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
March 2, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 19, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1561299
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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