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Completed

NCT Number: NCT01474759

Portion Size Strategies for Management of Body Weight

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advice on diet, physical activity, and behavior change

Behavioral

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.

Instruction in food portion size

Behavioral

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.

Provision of pre-portioned foods

Other

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.

Advice on healthy eating for weight loss

Behavioral

Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.

Primary outcomes

  1. Change in body weight

    Time frame: Months 0 to 12

    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 outcomes

  1. Change in portion size selection, perception, and knowledge

    Time frame: Months 0, 3, 6, & 12

    Computerized assessment of various foods (for self-selected portion sizes, estimation of calorie content, and satiety value) and general knowledge about portion size

  2. Change in portion size consumption

    Time frame: Months 0, 3, 6, & 12

    Portion sizes consumed in various food categories as assessed by diet recalls and diet records

  3. Change in blood biomarkers

    Time frame: Months 0, 3, 6, & 12

    Fasting lipids, glucose, insulin, and calculated insulin resistance

  4. Change in waist circumference

    Time frame: Months 0, 3, 6, & 12

  5. Change in blood pressure

    Time frame: Months 0, 3, 6, & 12

  6. Change in dietary intakes

    Time frame: Months 0, 3, 6, 9, & 12

    Energy intake, nutrient intakes, dietary energy density, food group intakes, and diet quality from three days of 24-hour diet recalls

  7. Change in step counts

    Time frame: Months 0, 3, 6, 9, & 12

    Daily step counts from pedometers

  8. Change in attitudes and behaviors related to food and eating

    Time frame: Months 0, 1, 3, 6, & 12

    Self-reported eating attitudes and behaviors on multiple questionnaires

  9. Change in psychosocial characteristics

    Time frame: Months 0, 3, 6, & 12

    Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy

  10. Intervention adherence

    Time frame: Month 12

    Number of sessions attended, number of diet and activity records completed, and frequency of using intervention strategies during the entire trial

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2011
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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