Overview

This trial is active, not recruiting.

Condition weight regain
Treatments multimodal lifestyle intervention, placebo
Sponsor Charite University, Berlin, Germany
Collaborator German Research Foundation
Start date October 2009
End date July 2012
Trial size 320 participants
Trial identifier NCT00850629, EA2/017/09

Summary

The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo
placebo
no intervention, only follow up
(Experimental)
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults

Primary Outcomes

Measure
Weight regain during lifestyle intervention in children, adolescents and adults vs. placebo
time frame: 18 month

Secondary Outcomes

Measure
Evaluation of several endocrine parameters during lifestyle intervention in children, adolescents and adults
time frame: 18 month

Eligibility Criteria

Male or female participants from 10 years up to 90 years old.

Inclusion Criteria: - BMI > 27 kg/m2 (adults) Exclusion Criteria: - weight loss of more than 5kg in the last 2 months - pregnancy, breastfeeding - patients with: - heart failure - impaired hepatic or renal function - anaemia - disturbed coagulation - infection, malabsorption - severe hypertension - any other endocrine disorder - changes of smoking habits or diets within the last 3 months prior to study inclusion

Additional Information

Official title Hormonal Regulation of Body Weight Maintenance
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.