Portion Size Strategies for Management of Body Weight

NCT ID: NCT01474759

Last Updated: 2015-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Portion size instruction

Advice on diet, physical activity, and behavior change. Instruction in food portion size.

Group Type EXPERIMENTAL

Advice on diet, physical activity, and behavior change

Intervention Type 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

Intervention Type 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.

Pre-portioned foods

Advice on diet, physical activity, and behavior change. Provision of pre-portioned foods.

Group Type EXPERIMENTAL

Advice on diet, physical activity, and behavior change

Intervention Type 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.

Provision of pre-portioned foods

Intervention Type 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.

Comparison

Advice on diet, physical activity, and behavior change. Advice on healthy eating for weight loss.

Group Type ACTIVE_COMPARATOR

Advice on diet, physical activity, and behavior change

Intervention Type 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.

Advice on healthy eating for weight loss

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbara J. Rolls

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara J. Rolls, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Penn State University Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Roe LS, Rolls BJ. Which strategies to manage problem foods were related to weight loss in a randomized clinical trial? Appetite. 2020 Aug 1;151:104687. doi: 10.1016/j.appet.2020.104687. Epub 2020 Mar 29.

Reference Type DERIVED
PMID: 32234531 (View on PubMed)

James BL, Loken E, Roe LS, Rolls BJ. The Weight-Related Eating Questionnaire offers a concise alternative to the Three-Factor Eating Questionnaire for measuring eating behaviors related to weight loss. Appetite. 2017 Sep 1;116:108-114. doi: 10.1016/j.appet.2017.04.023. Epub 2017 Apr 22.

Reference Type DERIVED
PMID: 28442337 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DK059853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PortionSize101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diet and Body Composition
NCT01530724 COMPLETED PHASE3
Liking of Snack Foods - Sub-Study 1
NCT00200213 COMPLETED NA