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Portion Size Strategies for Management of Body Weight

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University
ClinicalTrials.gov Identifier:
NCT01474759
First received: November 15, 2011
Last updated: October 3, 2014
Last verified: October 2014
  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 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. A third group will receive a basic nutritional program to promote weight loss.

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
Behavioral: Advice on healthy eating for weight loss

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:
  • Change in body weight [ Time Frame: Months 0 to 12 ] [ Designated as safety issue: No ]
    Body weight will be measured at multiple time points during the 12-month trial; the main outcome will be the weight trajectory across this time


Secondary Outcome Measures:
  • Change in portion size selection, perception, and knowledge [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
    Computerized assessment of various foods (for self-selected portion sizes, estimation of calorie content, and satiety value) and general knowledge about portion size

  • Change in portion size consumption [ 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

  • Change in blood biomarkers [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
    Fasting lipids, glucose, insulin, and calculated insulin resistance

  • Change in waist circumference [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
  • Change in dietary intakes [ Time Frame: Months 0, 3, 6, 9, & 12 ] [ Designated as safety issue: No ]
    Energy intake, nutrient intakes, dietary energy density, food group intakes, and diet quality from three days of 24-hour diet recalls

  • Change in step counts [ Time Frame: Months 0, 3, 6, 9, & 12 ] [ Designated as safety issue: No ]
    Daily step counts from pedometers

  • Change in attitudes and behaviors related to food and eating [ Time Frame: Months 0, 1, 3, 6, & 12 ] [ Designated as safety issue: No ]
    Self-reported eating attitudes and behaviors on multiple questionnaires

  • Change in psychosocial characteristics [ Time Frame: Months 0, 3, 6, & 12 ] [ Designated as safety issue: No ]
    Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy

  • Intervention adherence [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Number of sessions attended, number of diet and activity records completed, and frequency of using intervention strategies during the entire trial


Enrollment: 186
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
Advice on diet, physical activity, and behavior change. Instruction in food portion size.
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.
Experimental: Pre-portioned foods
Advice on diet, physical activity, and behavior change. Provision of 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 and will be taught effective ways to incorporate them into their daily diet.
Active Comparator: Comparison
Advice on diet, physical activity, and behavior change. Advice on healthy eating for weight loss.
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: Advice on healthy eating for weight loss
Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474759

Locations
United States, Pennsylvania
Penn State University Laboratory for the Study of Human Ingestive Behavior
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: October 3, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on November 27, 2014