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

NCT02230111 | Completed

• 1 other identifier: 2013-170
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Women; Caloric restriction; Cognitive dietary restraint; Eating behaviours; Food habits; Appetite sensations; Stress; Weight management

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline (t=0) and immediately after the 4-week intervention (t=4 wk)

• 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.

  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 Outcomes (10)

• Eating behaviours

  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

• Dietary intakes

  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

• Weight

  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

• Waist circumference

  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

• Hip circumference

  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

Study Arms (2)

Energy restriction plus CDR group

EXPERIMENTAL

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.

Behavioral: Energy restriction plus CDR

Energy restriction without CDR group

EXPERIMENTAL

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.

Behavioral: Energy restriction without CDR

Interventions

Energy restriction plus CDR BEHAVIORAL

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.

Energy restriction plus CDR group

Energy restriction without CDR BEHAVIORAL

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.

Energy restriction without CDR group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Danone Institute International: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Overweight; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Simone Lemieux, Ph.D., Dt.P

  Department of food sciences and nutrition / Institute of Nutrition and Functional Foods (INAF), Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

CA (1)