NCT04293055

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 4, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 31, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

February 27, 2020

Results QC Date

August 13, 2024

Last Update Submit

December 19, 2024

Conditions

Keywords

Phone coachingDietExercise

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Body Weight From Baseline to Month 12

    Baseline and Month 12

Secondary Outcomes (1)

  • Percent Weight Change Over the Coaching Period

    Trigger date and 40 days post-trigger date

Study Arms (2)

Maintenance program+possibility of phone coaching

EXPERIMENTAL

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 programBehavioral: Phone coaching

Maintenance program only

ACTIVE COMPARATOR

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

Interventions

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

Maintenance program onlyMaintenance program+possibility of phone coaching
Phone coachingBEHAVIORAL

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.

Maintenance program+possibility of phone coaching

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not currently enrolled in another weight management program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Hayes JF, Ross KM, Pellegrini C, Wing RR, Webster J, Derrick A, Tobin SY, Unick JL. Brief coaching intervention to reverse weight regain during weight loss maintenance: a preliminary randomized controlled trial. J Behav Med. 2025 Aug;48(4):706-714. doi: 10.1007/s10865-025-00582-x. Epub 2025 Jun 26.

MeSH Terms

Conditions

ObesityWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Results Point of Contact

Title
Dr. Jacqueline Hayes
Organization
The Miriam Hospital

Study Officials

  • Jessica L Unick, PhD

    The Miriam Hospital's Weight Control and Diabetes Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Assistant Professor (Research)

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 3, 2020

Study Start

March 4, 2020

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

December 31, 2024

Results First Posted

December 31, 2024

Record last verified: 2024-12

Locations