Eat Well for Life: A Weight Loss Maintenance Study

NCT01849627 | Active Not Recruiting DMC

• 1 other identifier: 9141B
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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 estimated energy needs for maintenance) on weight loss maintenance.

Conditions

Obesity

Keywords

weight loss maintenance

Outcome Measures

Primary Outcomes (2)

• Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months

  Height, weight, and BMI will be assessed.

  0, 4, 10, 16, and 22 months

• Changes in diet from baseline at 4, 10, 16, and 22 months

  Three day food records will be used to assess energy, grams, energy density, macronutrients, fiber, and food group servings.

  0, 4, 10, 16, and 22 months

Secondary Outcomes (1)

• Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months

  0, 4, 10, 16, and 22 months

Study Arms (2)

Low-ED

EXPERIMENTAL

This condition will focus lowering on the energy density of the diet of the diet. This prescription does not include goals for any other nutrients, thus there are no energy goals.

Behavioral: Low-ED

Energy Balance

EXPERIMENTAL

This condition will focus have an energy balance prescription. Participants will be asked to consume a daily energy intake at estimated energy needs for weight loss maintenance.

Behavioral: Energy Balance

Interventions

Low-ED BEHAVIORAL

This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day.

Low-ED

Energy Balance BEHAVIORAL

Energy Balance will receive an individualized daily energy goal which will be their measured resting metabolic rate multiplied by a physical activity level (PAL) of 1.12 (men) or 1.14 (women) (low active).

Energy Balance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hollie A Raynor, PhD, RD, LDN

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 8, 2013
• Study Start: August 1, 2014
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

US (1)