Clincosm LogoSign in Get a demo

Phone Coaching for Weight Loss Maintenance

Sponsor
The Miriam Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04293055
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
45.9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether weight loss maintenance can be improved by providing individuals with 4 consecutive weeks of phone coaching during the maintenance period. Individuals who previously achieved and maintained a >=5% weight loss in a 1-year behavioral weight loss program will be provided with a low-intensity maintenance intervention. Some individuals will be selected to receive phone coaching. Assessments of weight, physical activity, and other weight-related behaviors will occur at baseline, 6 months, and 1 year.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Maintenance program
  • Behavioral: Phone coaching
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Examination of Phone Coaching as a Weight Loss Maintenance Strategy
Actual Study Start Date :
Mar 4, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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).

Behavioral: Maintenance program
1-year weight loss maintenance program, consisting of monthly newsletters

Behavioral: Phone coaching
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.

Behavioral: Maintenance program
1-year weight loss maintenance program, consisting of monthly newsletters

Outcome Measures

Primary Outcome Measures

  1. Percent weight change at 6 months [6 months after study enrollment]

  2. Percent weight change at 12 months [12 months after study enrollment]

Secondary Outcome Measures

  1. Change in physical activity minutes (min/week) [12 months after study enrollment]

    Physical activity will be assessed via an Actigraph accelerometer which is worn on the waist

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 72 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Miriam Hospital's Weight Control and Diabetes Research Center Providence Rhode Island United States 02903

Sponsors and Collaborators

  • The Miriam Hospital

Investigators

  • Principal Investigator: Jessica L Unick, PhD, The Miriam Hospital's Weight Control and Diabetes Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Unick, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT04293055
Other Study ID Numbers:
  • 1561299
First Posted:
Mar 3, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jessica Unick, Assistant Professor (Research), The Miriam Hospital
phone coaching
diet
exercise
Additional relevant MeSH terms:
Body Weight
Weight Loss

Study Results

No Results Posted as of Apr 6, 2022