Total Lifestyle Coaching Pilot Study (TLC)

NCT ID: NCT03025217

Last Updated: 2019-02-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-arm pilot study of patients at the Revere Healthcare Center with a BMI greater than 25. The intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. Study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). Semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Weight Loss Telemedicine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TLC Program

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.

Group Type EXPERIMENTAL

Total Lifestyle Coaching (TLC)

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total Lifestyle Coaching (TLC)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. age 21 and older
2. body mass index (BMI) exceeds 25
3. speaks English
4. has access to a telephone
5. able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
6. overweight (BMI exceeds 25)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michelle Dossett, MD, PhD, MPH

Assistant Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30013821 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014P001549

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Women's Healthy Lifestyle Study
NCT00583726 COMPLETED NA