Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss \[Phase 1 (P1): 6 months\] and maintenance trial \[Phase 2 (P2): 12 months\] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• individuals with a BMI ≥30 and \<40 kg/m2

• aged between 18-50 years

• waist circumference \>102 cm in men and \>88 cm in women.

Locations
Other Locations
Canada
Department of Physical Education
RECRUITING
Québec
Contact Information
Primary
Vicky Drapeau, PhD
vicky.drapeau@fse.ulaval.ca
4186562131
Backup
Lucie Brunelle, MSc, RD
lucie.brunelle@kin.ulaval.ca
4186562131
Time Frame
Start Date: 2022-01-15
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 234
Treatments
Experimental: Non-restrictive satiating intervention
The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin).
Experimental: Conventional restrictive intervention + non-restrictive satiating intervention
Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)
Placebo_comparator: Minimal healthy guidelines
Considering recommendations from the latest Canadian Obesity Guidelines, the control group will receive a minimal intervention based on the Canada's Food Guide for Healthy Eating
Related Therapeutic Areas
Sponsors
Collaborators: University of Ottawa
Leads: Laval University

This content was sourced from clinicaltrials.gov