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Completed

NCT Number: NCT03025217

Total Lifestyle Coaching Pilot Study (TLC)

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Telemedicine Weight Loss

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

Total Lifestyle Coaching (TLC)

Behavioral

Primary outcomes

  1. Change in Weight

    Time frame: 26 weeks

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

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: 26 weeks

    Change in perceived stress as measured by the PSS-10 questionnaire administered at baseline (week 0) and post intervention (week 26). Score range is 0 - 40 with higher scores indicating higher perceived stress.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: TLC

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 19, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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