NCT02942589

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

October 19, 2016

Last Update Submit

October 20, 2016

Conditions

Keywords

Portion Size

Outcome Measures

Primary Outcomes (3)

  • 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

  • Difference in intake by weight across subject groups

    Weights (grams) of all food consumed

    Weeks 1, 2, 3, and 4

  • Difference in energy density consumed across subject groups

    Energy density (kcal/gram) of all food consumed

    Weeks 1, 2, 3, and 4

Secondary Outcomes (1)

  • Ratings of hunger and satiety across subject groups

    Weeks 1, 2, 3, and 4

Other Outcomes (2)

  • Ratings of food taste across subject groups

    Week 5

  • Ratings of food healthfulness across subject groups

    Week 5

Study Arms (4)

100% Portions

EXPERIMENTAL

Meal portion size: 100%

Other: Meal portion size

125% Portions

EXPERIMENTAL

Meal portion size: 125%

Other: Meal portion size

150% Portions

EXPERIMENTAL

Meal portion size: 150%

Other: Meal portion size

175% Portions

EXPERIMENTAL

Meal portion size: 175%

Other: Meal portion size

Interventions

100% Portions125% Portions150% Portions175% Portions

Eligibility Criteria

Age20 Years - 66 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant in the Portion-Control Strategies Trial (NCT01474759) OR
  • Community control who regularly eats three meals per day

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for the Study of Human Ingestive Behavior

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 24, 2016

Study Start

February 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 24, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations