Clinical trial NCT01474759: Portion Size Strategies for Management of Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-11-18
Enrollment: 186
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in body weight
timeFrame: Months 0 to 12
Secondary outcomes:
measure: Change in portion size selection, perception, and knowledge
timeFrame: Months 0, 3, 6, & 12
measure: Change in portion size consumption
timeFrame: Months 0, 3, 6, & 12
measure: Change in blood biomarkers
timeFrame: Months 0, 3, 6, & 12
measure: Change in waist circumference
timeFrame: Months 0, 3, 6, & 12
measure: Change in blood pressure
timeFrame: Months 0, 3, 6, & 12
measure: Change in dietary intakes
timeFrame: Months 0, 3, 6, 9, & 12
measure: Change in step counts
timeFrame: Months 0, 3, 6, 9, & 12
measure: Change in attitudes and behaviors related to food and eating
timeFrame: Months 0, 1, 3, 6, & 12
measure: Change in psychosocial characteristics
timeFrame: Months 0, 3, 6, & 12
measure: Intervention adherence
timeFrame: Month 12
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J. Rolls, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.