NCT03025217

Brief Summary

The investigators aim to develop, pilot and evaluate a new "Total Lifestyle Coaching" (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2014

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

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

February 20, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

January 17, 2017

Results QC Date

July 9, 2018

Last Update Submit

February 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Change in weight between baseline (week 0) and post intervention (week 26)

    26 weeks

Secondary Outcomes (1)

  • Perceived Stress Scale

    26 weeks

Study Arms (1)

TLC Program

EXPERIMENTAL

The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided.

Behavioral: Total Lifestyle Coaching (TLC)

Interventions

TLC Program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 21 and older
  • body mass index (BMI) exceeds 25
  • speaks English
  • has access to a telephone
  • able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
  • overweight (BMI exceeds 25)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chad-Friedman E, Pearsall M, Miller KM, Wheeler AE, Denninger JW, Mehta DH, Dossett ML. Total Lifestyle Coaching: A Pilot Study Evaluating the Effectiveness of a Mind-Body and Nutrition Telephone Coaching Program for Obese Adults at a Community Health Center. Glob Adv Health Med. 2018 Jul 4;7:2164956118784902. doi: 10.1177/2164956118784902. eCollection 2018.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Michelle Dossett
Organization
Massachusetts General Hospital

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Physician

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 19, 2017

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

November 1, 2016

Last Updated

February 20, 2019

Results First Posted

February 20, 2019

Record last verified: 2019-02