NCT01604954

Brief Summary

Weight management is a critical issue in developed countries where the prevalence of obesity is always increasing. While the mismatch of energy intake and energy expenditure is recognized as a leading cause of obesity, knowledge related to the determinants of healthy eating patterns are still an important issue to further address. Various nutrition-education campaigns have been implemented as a way to increase knowledge about healthy foods and facilitate the adoption of better eating behaviors. There is currently social and politic pressure on health authorities to increase availability of nutrition information as a way to tackle the obesity epidemic. Does nutrition information on food labels really contribute to improving dietary intake among the population and to helping them to better manage their body weight? Some evidence suggests that describing foods as healthy might have unintended enhancement effects on the acute amount of food and calories consumed. A better understanding of how and why nutrient and calorie labels influence acute and chronic intake is thus needed. This study investigate how providing nutritional information on food labels influences intake and eating-related variables over a 10-day period among women characterized by varying levels of adiposity. As it has never been investigated before, the present research will provide important knowledge on the long-term impacts of different food labeling strategies on the regulation of food intake. It will also help to determine whether weight status could influence the effects of perceptions about foods on intake, so that the investigators can identify individuals who mostly tend to overeat in specific situations. Consumer advocacy organizations are urging government to adopt policies regarding food labeling. Such research is thus of great relevance for the promotion of healthy body weight at the population level, as it will clearly contribute to assess how food labels should be used by health governing bodies in the context of the obesity epidemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2011

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

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

May 16, 2012

Last Update Submit

August 31, 2015

Conditions

Keywords

Food labeling

Outcome Measures

Primary Outcomes (1)

  • Mean ad libitum intake

    The mean amount per day of food eaten during the 10-day period (grams and calories).

    Up to 2 years after the beginning of the study

Secondary Outcomes (1)

  • Appetite sensations

    Up to 2 years after the beginning of the study

Study Arms (2)

Non-obese

OTHER

Non-obese women (BMI between 18.5 and 25 kg/m2)

Behavioral: Nutrient-labelBehavioral: Calorie-labelBehavioral: No label

Obese

OTHER

Obese women (BMI between 30 and 40 kg/m2)

Behavioral: Nutrient-labelBehavioral: Calorie-labelBehavioral: No label

Interventions

Nutrient-labelBEHAVIORAL

A label indicating that the lunch they will eat is low in saturated fat and free from trans fat will be posted on the containers.

Non-obeseObese
Calorie-labelBEHAVIORAL

A label indicating the amount of calories for a fixed serving plus information about daily caloric requirement ("The recommended daily caloric intake for an average adult is 2000 calories") will be posted on the containers.

Non-obeseObese
No labelBEHAVIORAL

Lunches will be free from labels, so that no nutritional information will be provided to the participants(control group).

Non-obeseObese

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable weight (± 2.5 kg) for at least 3 months prior to the study.
  • BMI between 18.5 and 25 kg/m2 for the non-obese group and BMI between 30 and 40 kg/m2 for the obese group.

You may not qualify if:

  • pregnant or lactating.
  • aversion to the foods in the study.
  • taking medication (e.g., corticosteroids,tricyclic antidepressants, atypical antipsychotics) and present chronic health problems (e.g.,food allergies, eating disorders, diabetes, hyperthyroidism) that could affect appetite measurements and food intake.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutraceuticals and Functionnal Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Véronique Provencher, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur sous octroi

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 24, 2012

Study Start

August 1, 2011

Primary Completion

May 1, 2013

Study Completion

April 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations