Appetite Control, Weight Loss, Weight Maintenance
Conditions
Brief 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.
Interventions
OTHERNon-restrictive satiating intervention
Diet group containing satiating foods
OTHERConventional restrictive intervention + non-restrictive satiating intervention
Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase
OTHERControl group
This group will receive minimal healthy guidelines
Sponsors
University of Ottawa
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Blinding participants is not possible due to the nature of the interventions. Individuals independent from the study and blinded to groups (e.g. statistician), will conduct the randomization and analyses while a research assistant, instructed not to discuss treatments with participants, will conduct the testing sessions.
Intervention model description
(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). \*P1=phase 1; P2=phase 2
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids) * being treated with insulin for type 2 diabetes * large body weight fluctuations (\>4 kg over last two months) * characterized by high restraint behaviour (score \>12, measured with the TFEQ) * history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire * performing \>150 min of moderate-vigorous intensity physical activity/week * use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (\>2 drinks/d) * consumption of \>5 cups of coffee/d * (pre)menopausal or pregnant women * diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers) * food allergies/intolerances to ingredients/foods in the satiating intervention * having a pacemaker (for fMRI) * taking sedatives or sleeping pills * symptoms of depression (\>20 on the BDI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 6 months | Body weight loss (kg) after Phases 1 and 2 |
| Body composition | 6 months | Body fat (using dual x-ray absorptiometry) |
| Hunger/Satiety | 6 months | using a visual analogue scale and measured in mm |
| Energy intake | 6 months | measured at an ad libitum meal in kilocalories |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol) | 18 months | measured in mmol/L |
| Blood pressure | 18 months | mmHg |
| Stress | 18 months | State-Trait Anxiety Inventory |
| neurobehavioural variables | 6 months | brain anatomy and activity in response to food cues (using fMRI) |
| Diet satisfaction | 18 months | Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree) |
| Anxiety | 18 months | Perceived Stress Scales |
| Eating Behaviours | 18 months | Three Factor Eating Behaviour Questionnaire |
| Depression Symptoms | 18 months | Beck Depression Inventory |
Countries
Canada
Contacts
Primary ContactVicky Drapeau, PhD
Backup ContactLucie Brunelle, MSc, RD
Outcome results
None listed