NCT01474759

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

November 15, 2011

Last Update Submit

May 14, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    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

    Months 0 to 12

Secondary Outcomes (10)

  • Change in portion size selection, perception, and knowledge

    Months 0, 3, 6, & 12

  • Change in portion size consumption

    Months 0, 3, 6, & 12

  • Change in blood biomarkers

    Months 0, 3, 6, & 12

  • Change in waist circumference

    Months 0, 3, 6, & 12

  • Change in blood pressure

    Months 0, 3, 6, & 12

  • +5 more secondary outcomes

Study Arms (3)

Portion size instruction

EXPERIMENTAL

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

Behavioral: Advice on diet, physical activity, and behavior changeBehavioral: Instruction in food portion size

Pre-portioned foods

EXPERIMENTAL

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

Behavioral: Advice on diet, physical activity, and behavior changeOther: Provision of pre-portioned foods

Comparison

ACTIVE COMPARATOR

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

Behavioral: Advice on diet, physical activity, and behavior changeBehavioral: Advice on healthy eating for weight loss

Interventions

Advice on diet, physical activity, and behavior changeBEHAVIORAL

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.

ComparisonPortion size instructionPre-portioned foods
Instruction in food portion sizeBEHAVIORAL

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.

Portion size instruction
Provision of pre-portioned foodsOTHER

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.

Pre-portioned foods
Advice on healthy eating for weight lossBEHAVIORAL

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

Comparison

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16803, United States

Location

Related Publications (2)

  • 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.

    PMID: 32234531DERIVED

  • 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.

    PMID: 28442337DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Nutrition AssessmentExerciseEducational Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Barbara J. Rolls, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 18, 2011

Study Start

July 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 15, 2015

Record last verified: 2015-05

Locations

US(1)