Efficacy and Feasibility of an Intermittent Weight Loss Program.

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT00395356

Collaborator

Fonds de la Recherche en Santé du Québec (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the study is to measure the effect of an approach including phases of active weight loss broken by weight stabilisation periods (named intermittent weight loss) on the metabolic profile.

First, the intermittent weight loss approach will contribute to create an artificial transitory steady state during the weight loss treatment that will help to minimize the adverse effects of the standard approach on muscle mass and resting metabolic rate. Second, despite a comparable fat mass loss, the intermittent weight loss approach will improve the metabolic profile to a greater degree compared to the standard approach. Finally, the intermittent weight loss approach will be associated with less weight regain after the treatment since the beneficial effect on muscle mass and metabolic rate.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: calorie controlled diet	N/A

Detailed Description

Excessive levels of body fat are associated with metabolic disturbances predictive of an increased risk of coronary heart disease (CAD). It is presently unclear as to the magnitude of weight loss needed to accrue metabolic benefits. Despite the effectiveness of weight loss to reduce obesity levels, studies have shown that only minor decreases in body weight (5-10%) are needed to clinically improve CAD risk factors. Our data suggested that a 10% reduction in body weight is as effective in improving the metabolic profile as a 20% decrease in body weight. Thus, the question are : " Is it possible to further improve the metabolic profile over that 5-10% weight loss threshold?" and "Could several 5-10% body weight loss (intermittent weight loss approach) have additive effects on the metabolic profile?". We would like to follow-up on these observation to better understand 1) the association between weight loss and improvements in the metabolic profile and 2) why minor decreases in body composition and body fat distribution are as effective as more important reduction.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Feasibility of an Intermittent Weight Loss Program: A Pilot Study.

Study Start Date :

Sep 1, 2005

Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Body composition (fat mass and lean body mass): after 0, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention []

Secondary Outcome Measures

Fasting lipids: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention []
Resting metabolic rate: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention []
Resting blood pressure: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention []
OGTT: baseline and 25 weeks []
Dietary habits: baseline,25 weeks and 12-month post-intervention []

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women who had stopped menstruating for more than 1 year
Waist circumference > 90 cm
Sedentary (< 2 times a week of structured exercise)
Non-smokers
Low to moderate alcohol consumers (< 2 drinks per day).

Exclusion Criteria:

We excluded subjects with the following conditions based on medical history and physical examination and on laboratory testing of kidney and liver functions, serum TSH, fasting glucose and lipid profile, and 75g-OGTT
Cardiovascular disease, peripheral vascular disease or stroke
Diabetes
Moderate to severe hypertension (resting blood pressure > 170/100 mm Hg);
Body weight fluctuation > 5 kg in the previous 6 months
Thyroid or pituitary disease
Hormonal replacement therapy at any time during the previous 6 months
Medication that could affect the metabolic profile