Bioimpedance Analysis for Follow-up of Dieters

Completed

• Conditions: Obesity
• Interventions: Other: Diet group

• Registration Number: NCT02975427
• Lead Sponsor: Baskent University Ankara Hospital

Brief Summary

Prospective, single arm, dietary intervention study.

Detailed Description

This prospective study was conducted during the period from December 2011 through June 2013 in the Department of Endocrinology and Metabolism of Başkent University.

We enrolled 185 participants who were admitted to hospital for weight loss therapy. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. At the end of the follow up, 103 participants attended to the research. Anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. We calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. Correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine whether abdominal BIA was better than simple anthropometric measurements and conventional BIA for assessing changes in metabolic variables.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-06
• Study Completion: 2014-03
• Study First Submitted: 2016-10-27
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Study First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months.

Exclusion Criteria

• Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. We also excluded patients who used any of these drugs after the initial evaluation.
• Participants who, at the second visit, reported that they failed to adhere to the diet.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diet group	Diet group	All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.

Primary Outcome Measures

Name	Time	Method
Value of abdominal BIA for the follow up of dieting individual	3 months (plus or minus 1 month)