Status:

ACTIVE_NOT_RECRUITING

Eat Well for Life: A Weight Loss Maintenance Study

Lead Sponsor:

The University of Tennessee, Knoxville

Conditions:

Obesity

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily energy intake at e...

Detailed Description

Obesity increases the risk of several health conditions. Weight loss of 5-10% of initial weight reduces the risk of several diseases. This degree of weight loss is achievable in behavioral obesity pro...

Eligibility Criteria

Inclusion

  • Age between 18 and 70 years
  • Body mass index (BMI) between 27 and 45 kg/m2

Exclusion

  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping
  • Report major psychiatric diseases or organic brain syndromes.
  • Are currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost \> 5% of body weight during the past 6 months
  • Have had bariatric surgery for weight loss or are planning to have bariatric surgery in the next 22 months
  • Intend to move outside of the metropolitan area within the time frame of the investigation
  • Are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation
  • Report not being able to consume meal replacements
  • To participate in the weight loss maintenance phase, participants will need to lose equal to or greater than 8% of their body weight from the baseline measure at the conclusion of the 4-month weight loss phase.

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

345 Patients enrolled

Trial Details

Trial ID

NCT01849627

Start Date

August 1 2014

End Date

December 31 2025

Last Update

April 3 2025

Active Locations (1)

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1

University of Tennessee

Knoxville, Tennessee, United States, 37996