Portion Size Strategies for Management of Body Weight

This study is currently recruiting participants.
Verified May 2013 by Penn State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University
ClinicalTrials.gov Identifier:
NCT01474759
First received: November 15, 2011
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two different approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. During a 6-month intervention phase, 300 overweight and obese women will meet biweekly with dietitians for individual instruction; this will be followed by 6 months of monthly meetings to promote the maintenance of behavior changes and weight loss. Participants will be randomly assigned to one of three equally intensive intervention programs. All three groups will receive basic nutritional and behavioral intervention to promote weight loss. In addition, the portion-size instruction group will be given training in selecting portions and in the use of portion control tools such as measuring implements and charts. The instruction will include an innovative approach based on our previous research, which shows that consuming larger portions of foods that are low in energy density (such as vegetables and water- rich foods) enhances satiety and reduces energy intake. A second group of participants will be provided with pre-portioned foods (such as frozen entrées) for two meals daily at the beginning of the trial; the frequency of food provision will be reduced over the course of the intervention phase. Participants will be instructed in other methods for managing influences on food intake in their personal environment. The third group will receive the basic nutritional program supplemented with additional information on healthy eating during weight loss.

It is hypothesized that the two portion-control interventions will result in increased weight loss during the intervention phase, but that the maintenance of weight loss will depend on sustained changes in the acquisition and application of portion size knowledge. The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.


Condition Intervention
Obesity
Behavioral: Advice on diet, physical activity, and behavior change
Behavioral: Instruction in food portion size
Other: Provision of pre-portioned foods

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Body weight [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Portion size selection [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
    Computerized assessment of portion size selection of various foods

  • Portion size intake [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
    Portion sizes consumed in various food categories as assessed by diet recalls and diet records.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Portion size instruction Behavioral: Advice on diet, physical activity, and behavior change
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
Behavioral: Instruction in food portion size
Individuals assigned to this program will participate in individual instructional sessions with specialized materials and tools that address food selection and choosing appropriate portion sizes of various foods. Instruction will focus on strategies for maintaining satiety while limiting calorie intake by choosing smaller portions of high-energy dense foods and larger portions of low-energy-dense foods. Individuals will be educated in portion size recognition and estimation and trained in the use of portion-control tools such as measuring implements, portion-labeled plates and bowls, and booklets of reference photographs and charts.
Experimental: Pre-portioned foods Behavioral: Advice on diet, physical activity, and behavior change
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
Other: Provision of pre-portioned foods
Individuals assigned to this program will be provided with commercially available pre-portioned foods (PPFs) starting with two meals per day and reducing in frequency during the 6-month intervention phase. In the instructional sessions, individuals will be taught the most effective way to incorporate the PPFs into their daily diet and will be trained to pay attention to the calorie labels on these foods so that they gain a better understanding of what constitutes appropriate portions for their calorie goals. After provision of PPFs is ended, participants will be encouraged to purchase similar PPFs in order to stay within their daily energy goals.
Active Comparator: Comparison Behavioral: Advice on diet, physical activity, and behavior change
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index of 28 to 45 kg/m squared
  • Able to safely engage in physical activity (walking)
  • Able to attend regular instructional sessions at University Park, Pennsylvania

Exclusion Criteria:

  • have a medical condition diagnosed by a physician that precludes participation
  • report symptoms indicative of depression or disordered eating
  • report serious food allergies or intolerance
  • current or planned participation in a weight-loss program
  • pregnant or lactating or planning to become pregnant in the next 18 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474759

Contacts
Contact: Jennifer S. Meengs, R.D. 814-863-8482 jas138@psu.edu

Locations
United States, Pennsylvania
Penn State University Laboratory for the Study of Human Ingestive Behavior Recruiting
University Park, Pennsylvania, United States, 16803
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Barbara J. Rolls, PhD Penn State University
  More Information

No publications provided

Responsible Party: Barbara J. Rolls, Principal Investigator, Penn State University
ClinicalTrials.gov Identifier: NCT01474759     History of Changes
Other Study ID Numbers: PortionSize101, R01DK059853
Study First Received: November 15, 2011
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013