Healthy Eating Patterns During a Lifestyle Intervention

Obesity Clinical Trial

— HEP  

Official title:

Healthy Eating Patterns During a Lifestyle Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01682317
• Other study ID #: UTK IRB# FWA 6629
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

Description:

Little intervention research has been conducted to examine the influence of eating frequency (EF) on weight loss. It has been hypothesized an increased EF improves appetite control, assisting with better regulation of energy intake, thus decreasing body mass index. Unfortunately, outcomes have not shown greater appetite control with increased EF. Instead, trends favor a lower EF reducing energy intake thereby producing greater weight loss than a higher eating frequency. Thus, a lower eating frequency may lower energy intake via behavioral mechanisms. At thit time no research has examined the behavioral mechanisms that may mediate the relationship between a lower eating frequency and superior adherence to an energy-restricted diet.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 18 and 65 years

• healthy overweight and obese men and women

• body mass index (BMI) between 27 and 45 kg/m squared

Exclusion Criteria:

• report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR- Q)

• report being unable to walk for 2 blocks (1/4 mile) without stopping

• are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months

• diagnosed with type 1 or 2 diabetes

• have had bariatric surgery or are planning to have bariatric surgery in the next 4 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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Eating Frequency
Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, < 30% energy from fat dietary prescription, and a physical activity goal of 200 minutes/week. Participants will be randomized to one of two conditions differing in EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).

Locations

Country	Name	City	State
United States	Healthy Eating and Activity Laboratory, University of Tennessee	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet	Diet (eating frequency, kilocalories, macronutrients)	0 and 8 weeks
Secondary	Ecological Momentary Assessment (EMA)	To evaluate the behavioral mechanisms of eating frequency, PalmPilot-based EMA will be used to collect real-time information on consumption cues.	0 and 8 weeks
Secondary	Anthropometrics	Height (0 weeks only), weight and body mass index	0 and 8 weeks
Secondary	Binge Eating	Assessed by the Eating Disorder Examination-Questionnaire (EDE-Q), which is a 36-item questionnaire derived from the Eating Disorders Examination interview.	0 and 8 weeks
Secondary	Physical Activity	Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.	0 and 8 weeks