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Impact of Cognitive Dietary Restraint on Perceived Stress, Appetite Sensations, Food Cravings During Energy Restriction

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Energy restriction plus CDR
Energy restriction without CDR
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Women, Caloric restriction, Cognitive dietary restraint, Eating behaviours, Food habits, Appetite sensations, Stress, Weight management

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Premenopausal women (age between 20 to 50 years) from de Quebec City metropolitan area
  • Have at least one child (2 to 19 years) living at home
  • Body mass index between 25 and 45 kg/m2
  • Stable body weight (+/- 2,5 kg) for at least 3 months before the beginning of the study

Exclusion Criteria:

  • Women with endocrine disorders, cardiovascular events and type 2 diabetes
  • Women with medication that could affect dependent variables measured (namely medication affecting appetite)
  • Smokers
  • Women with food allergies or food aversion that could impede compliance to the diet
  • Pregnant and lactating women
  • Women with psychiatric disorders or eating disorders (e.g. bulimia)

Sites / Locations

  • Institute of Nutrition and Functional Foods (INAF), Laval University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Energy restriction plus CDR group

Energy restriction without CDR group

Arm Description

Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. They will be told that they are on a low-calorie diet and strategies to increase CDR will be used.

Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. To have a condition of energy restriction without CDR, they will not be told that they are on a low-calorie diet and non-restrictive messages will be used.

Outcomes

Primary Outcome Measures

Appetite sensations
Measurements of appetite sensations will be performed following a standardized meal. After a 12-hour overnight fast, each woman will be invited to eat a standardized breakfast (600 kcal) and to rate her appetite sensations according to 4 visual analog scales (ranging from 0 to 150 mm): desire to eat, hunger, fullness, and prospective food consumption. Appetite sensations will be recorded before, immediately after, and at 10, 20, 30, 40, 50, and 60 minutes after the consumption of the standardized breakfast.
Stress (cortisol concentrations and perceived stress)
Cortisol concentrations will be measured by three samples of morning salivary taken immediately at the time of awakening as well as 15 minutes and 30 minutes thereafter. The Perceived Stress Scale will be used to measure perceived stress.

Secondary Outcome Measures

Eating behaviours
Food craving (Food craving inventory); Cognitive dietary restraint, disinhibition, and susceptibility to hunger (Three factor eating questionnaire); Restrained eating, external eating and emotional eating (Dutch eating behavior questionnaire); Restraint scale; Women's attitude toward their children's eating behaviours (Child feeding questionnaire).
Dietary intakes
A web-based self-administered food frequency questionnaire will be completed.
Weight
Weight will be measured.
Waist circumference
Waist circumference will be measured.
Hip circumference
Hip circumference will be measured.
Body mass index
Body mass index will be calculated from measured height and weight.
Lipid profile
Basic lipid profile will be measured.
Fasting glycemia
Fasting glycemia will be measured.
Fasting insulinemia
Fasting insulinemia will be measured.
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured.

Full Information

First Posted
August 29, 2014
Last Updated
August 31, 2015
Sponsor
Laval University
Collaborators
Danone Institute International
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1. Study Identification

Unique Protocol Identification Number
NCT02230111
Brief Title
Impact of Cognitive Dietary Restraint on Perceived Stress, Appetite Sensations, Food Cravings During Energy Restriction
Official Title
Impact of Cognitive Dietary Restraint on Perceived Stress, Appetite Sensations and Food Cravings During Energy Restriction in Women With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Danone Institute International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to measure the effects of a reduced-calorie low energy density diet with and without increased cognitive dietary restraint (CDR) on stress (biological markers and perceived stress), eating behaviours, appetite sensations, anthropometric variables and women's attitude toward their children's eating behaviours in premenopausal overweight/obese women in both the short term (immediately after the end of the 4-week intervention) and longer term (3 months after the end of the intervention). The investigators hypothesize that cortisol concentrations are higher, appetite sensations are increased (i.e. increased global appetite score) and food cravings are more prevalent in women of the energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group after the 4-week intervention. They also hypothesize that perceived stress is higher and food cravings are more prevalent in women of the energy-restriction-plus-CDR group than in women of the energy-restriction-without-CDR group at 3-month post intervention. They hypothesize that no significant difference in body weight changes is observed between the two groups and that maternal restriction of their child's eating is higher in the energy-restriction-plus-CDR group than in the energy-restriction-without-CDR group both after the 4-week intervention and at the 3-month follow-up.
Detailed Description
It is clear that a large proportion of individuals regain weight following dietary weight loss interventions most likely because of homeostatic and non-homeostatic factors favouring a return to initial energy status. However, studies performed to date have documented these effects in the context of interventions favouring both energy restriction and CDR. Thus, the difference between a state of energy restriction alone and a state of energy restriction combined to CDR on factors regulating energy balance is not known. In order to study this important question appropriately, we need to create a condition of energy restriction without increasing CDR, which can only be achieved with a satiating diet (i.e. well-balanced low energy density diet). This is easier to create in the context of a controlled intervention in which all foods and drinks are provided. We propose to create, in a controlled context, an energy restriction for which subjects will be blinded i.e. they will consume less energy than their energy needs without knowing that they are restrained. Such a design will permit to document for the first time the independent effects of CDR in the context of a reduced calorie diet on factors associated with the regulation of energy balance. The proposed study will also allow exploring the impact of increasing CDR on women's attitude toward their children's eating behaviours. Taken all together, results arising from the proposed study will better position the relevance of developing weight loss approaches not focusing on CDR to favour healthy weight management for women and their family. Data will be collected before and after the 4-week intervention, as well as 3 months after the end of the intervention. In order to appropriately test our hypotheses, we cannot state the real purpose of the study in the informed consent form and women will be told that it is a study about the impact of diet on blood pressure. However, at the end of the study, women will be debriefed and will sign a second informed consent form in which the true purpose of the study will be explained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Women, Caloric restriction, Cognitive dietary restraint, Eating behaviours, Food habits, Appetite sensations, Stress, Weight management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy restriction plus CDR group
Arm Type
Experimental
Arm Description
Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. They will be told that they are on a low-calorie diet and strategies to increase CDR will be used.
Arm Title
Energy restriction without CDR group
Arm Type
Experimental
Arm Description
Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. To have a condition of energy restriction without CDR, they will not be told that they are on a low-calorie diet and non-restrictive messages will be used.
Intervention Type
Behavioral
Intervention Name(s)
Energy restriction plus CDR
Intervention Description
Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. In the condition in which an increase in CDR will be induced, women will be told at the beginning of the study and will be reminded throughout the 4-week duration of the experimental condition that they are on a low-calorie diet and that it is important not to eat more than what is provided and that they should strictly avoid non-study food if they want to lose weight and improve their blood pressure. Subjects will receive feedback about their weight trajectory. After the 4-week controlled intervention women will then receive further information and advices to pursue their weight loss on their own and keeping on with strategies relying on an increase in CDR.
Intervention Type
Behavioral
Intervention Name(s)
Energy restriction without CDR
Intervention Description
Subjects will receive the same low-calorie diet (85% of their energy needs) for 4 weeks but will not be told that they are on an energy-deficit diet. They will be told at the beginning of the study that the food provided cover all their nutrient needs and that they should eat until satiation. There will be no emphasis on body weight and subjects will be reminded that the aim of the intervention is to document the effects of a diet rich in vegetables and fruits on blood pressure. After the 4-week controlled diet, participants will be taught about the impact of a low energy density diet on satiation and satiety. They will receive further information and advices (with non-restrictive messages) to incorporate more vegetables and fruits in their usual diet.
Primary Outcome Measure Information:
Title
Appetite sensations
Description
Measurements of appetite sensations will be performed following a standardized meal. After a 12-hour overnight fast, each woman will be invited to eat a standardized breakfast (600 kcal) and to rate her appetite sensations according to 4 visual analog scales (ranging from 0 to 150 mm): desire to eat, hunger, fullness, and prospective food consumption. Appetite sensations will be recorded before, immediately after, and at 10, 20, 30, 40, 50, and 60 minutes after the consumption of the standardized breakfast.
Time Frame
At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
Title
Stress (cortisol concentrations and perceived stress)
Description
Cortisol concentrations will be measured by three samples of morning salivary taken immediately at the time of awakening as well as 15 minutes and 30 minutes thereafter. The Perceived Stress Scale will be used to measure perceived stress.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and for the perceived stress also at 3 months (t=3 mo) after the end of the intervention
Secondary Outcome Measure Information:
Title
Eating behaviours
Description
Food craving (Food craving inventory); Cognitive dietary restraint, disinhibition, and susceptibility to hunger (Three factor eating questionnaire); Restrained eating, external eating and emotional eating (Dutch eating behavior questionnaire); Restraint scale; Women's attitude toward their children's eating behaviours (Child feeding questionnaire).
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
Title
Dietary intakes
Description
A web-based self-administered food frequency questionnaire will be completed.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
Title
Weight
Description
Weight will be measured.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
Title
Waist circumference
Description
Waist circumference will be measured.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
Title
Hip circumference
Description
Hip circumference will be measured.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
Title
Body mass index
Description
Body mass index will be calculated from measured height and weight.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention
Title
Lipid profile
Description
Basic lipid profile will be measured.
Time Frame
At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
Title
Fasting glycemia
Description
Fasting glycemia will be measured.
Time Frame
At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
Title
Fasting insulinemia
Description
Fasting insulinemia will be measured.
Time Frame
At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)
Title
Systolic and diastolic blood pressure
Description
Systolic and diastolic blood pressure will be measured.
Time Frame
At baseline (t=0), immediately after the 4-week intervention (t=4 wk), and 3 months (t=3 mo) after the end of the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal women (age between 20 to 50 years) from de Quebec City metropolitan area Have at least one child (2 to 19 years) living at home Body mass index between 25 and 45 kg/m2 Stable body weight (+/- 2,5 kg) for at least 3 months before the beginning of the study Exclusion Criteria: Women with endocrine disorders, cardiovascular events and type 2 diabetes Women with medication that could affect dependent variables measured (namely medication affecting appetite) Smokers Women with food allergies or food aversion that could impede compliance to the diet Pregnant and lactating women Women with psychiatric disorders or eating disorders (e.g. bulimia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Lemieux, Ph.D., Dt.P
Organizational Affiliation
Department of food sciences and nutrition / Institute of Nutrition and Functional Foods (INAF), Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutrition and Functional Foods (INAF), Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

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Impact of Cognitive Dietary Restraint on Perceived Stress, Appetite Sensations, Food Cravings During Energy Restriction

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