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Phone Coaching for Weight Loss Maintenance

Primary Purpose

Obesity, Weight Loss

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maintenance program
Phone coaching
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring phone coaching, diet, exercise

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Miriam Hospital's Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maintenance program+possibility of phone coaching

Maintenance program only

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Percent weight change at 6 months
Percent weight change at 12 months

Secondary Outcome Measures

Change in physical activity minutes (min/week)
Physical activity will be assessed via an Actigraph accelerometer which is worn on the waist

Full Information

First Posted
February 27, 2020
Last Updated
April 5, 2022
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04293055
Brief Title
Phone Coaching for Weight Loss Maintenance
Official Title
Examination of Phone Coaching as a Weight Loss Maintenance Strategy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
phone coaching, diet, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maintenance program+possibility of phone coaching
Arm Type
Experimental
Arm Description
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).
Arm Title
Maintenance program only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintenance program
Intervention Description
1-year weight loss maintenance program, consisting of monthly newsletters
Intervention Type
Behavioral
Intervention Name(s)
Phone coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent weight change at 6 months
Time Frame
6 months after study enrollment
Title
Percent weight change at 12 months
Time Frame
12 months after study enrollment
Secondary Outcome Measure Information:
Title
Change in physical activity minutes (min/week)
Description
Physical activity will be assessed via an Actigraph accelerometer which is worn on the waist
Time Frame
12 months after study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Unick, PhD
Organizational Affiliation
The Miriam Hospital's Weight Control and Diabetes Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital's Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Phone Coaching for Weight Loss Maintenance

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