Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02942589
Other study ID # PortionSize103
Secondary ID R01DK059853
Status Completed
Phase N/A
First received October 19, 2016
Last updated October 20, 2016
Start date February 2014
Est. completion date May 2015

Study information

Verified date October 2016
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test whether food intake in response to large portion sizes differs between women who have received portion-control training and women who have not received such training. In a crossover design, women come to the laboratory on four occasions to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is determined for each meal. Participants are from two groups: women who completed a one-year weight-loss trial in which they were trained in portion-control strategies, and women who had not received such training (community controls).


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 66 Years
Eligibility Inclusion Criteria:

- Participant in the Portion-Control Strategies Trial (NCT01474759) OR

- Community control who regularly eats three meals per day

Exclusion Criteria:

- Score on the Eating Attitudes Test indicating symptoms of disordered eating

- Score on the Zung or Beck questionnaires indicating symptoms of depression

- Food allergies or restrictions

- Dislike for foods served in the study

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Meal portion size


Locations

Country Name City State
United States Laboratory for the Study of Human Ingestive Behavior University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Ratings of food taste across subject groups 100-point visual analog scales Week 5 No
Other Ratings of food healthfulness across subject groups 100-point visual analog scales Week 5 No
Primary Difference in energy intake across subject groups Calculated energy intake (kcal) based on weight and energy density of food consumed Weeks 1, 2, 3, and 4 No
Primary Difference in intake by weight across subject groups Weights (grams) of all food consumed Weeks 1, 2, 3, and 4 No
Primary Difference in energy density consumed across subject groups Energy density (kcal/gram) of all food consumed Weeks 1, 2, 3, and 4 No
Secondary Ratings of hunger and satiety across subject groups 100-point visual analog scales Weeks 1, 2, 3, and 4 No
See also
  Status Clinical Trial Phase
Completed NCT02755558 - Effects of Energy Density and Portion Size of Milk in Preschool Children N/A
Completed NCT01684332 - Postprandial Response to Different Jams N/A
Completed NCT01525186 - Observational Study of Parental Feeding Practices to Improve Child's Food Intake and Weight Status N/A
Completed NCT02897570 - Metabolic and Neurofunctional Responses to Breakfasts N/A
Completed NCT02299531 - Effects of Portion Size and Energy Density of a Single Meal in Preschool Children N/A
Completed NCT02369588 - Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults N/A
Completed NCT01557218 - Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack N/A
Completed NCT01725347 - Validation of a Digital Diet Method for Use With Preschoolers N/A
Terminated NCT02568007 - Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders Phase 4
Completed NCT02745405 - Implications of Wearing a Fat Suit N/A