- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682317
Healthy Eating Patterns During a Lifestyle Intervention (HEP)
June 17, 2023 updated by: Hollie Raynor, The University of Tennessee, Knoxville
The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- Healthy Eating and Activity Laboratory, University of Tennessee
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Three Meal
Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.
|
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).
|
Experimental: Grazing
Participants in the increased eating frequency condition will be instructed to eat > 100 kcals every 2-3 hours.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diet
Time Frame: 0 and 8 weeks
|
Diet (eating frequency, kilocalories, macronutrients)
|
0 and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ecological Momentary Assessment (EMA)
Time Frame: 0 and 8 weeks
|
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
|
Anthropometrics
Time Frame: 0 and 8 weeks
|
Height (0 weeks only), weight and body mass index
|
0 and 8 weeks
|
Binge Eating
Time Frame: 0 and 8 weeks
|
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
|
Physical Activity
Time Frame: 0 and 8 weeks
|
Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.
|
0 and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hollie A Raynor, PhD, RD, University of Tennessee
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2012
Primary Completion (Actual)
December 31, 2018
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 5, 2012
First Submitted That Met QC Criteria
September 5, 2012
First Posted (Estimated)
September 10, 2012
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 17, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTK IRB# FWA 6629
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Eating Frequency
-
Fred Hutchinson Cancer CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Hospices Civils de LyonTerminated
-
Clinical Nutrition Research Centre, SingaporeCompletedCardiovascular Disease | Metabolic Disease
-
Centre Hospitalier Universitaire VaudoisAdvicenne PharmaCompleted
-
City, University of LondonCompleted
-
Texas Christian UniversityCompletedOral Intake ReducedUnited States
-
Centro Universitario La SalleCompletedChronic Pain | Neck Pain | Myofascial Pain SyndromeSpain
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH); Headspace... and other collaboratorsCompletedBehavioral Symptoms | Stress | Sleep | Health Behavior | Weight, Body | PsychologicalUnited States
-
Universidad Autonoma del Estado de MexicoCompleted