Penn State University Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16803, United States
NCT Number: NCT01474759
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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Notify Me20 year–65 year
Female
Interventional
Not applicable
University Park, Pennsylvania, 16803, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.
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
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
Time frame: Months 0, 3, 6, & 12
Portion sizes consumed in various food categories as assessed by diet recalls and diet records
Time frame: Months 0, 3, 6, & 12
Fasting lipids, glucose, insulin, and calculated insulin resistance
Time frame: Months 0, 3, 6, & 12
Time frame: Months 0, 3, 6, & 12
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
Time frame: Months 0, 3, 6, 9, & 12
Daily step counts from pedometers
Time frame: Months 0, 1, 3, 6, & 12
Self-reported eating attitudes and behaviors on multiple questionnaires
Time frame: Months 0, 3, 6, & 12
Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy
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
Penn State University
Other
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