Implications of Self-weighing During Weight Loss Treatment

Not Applicable

• Conditions: Signs and Symptoms; Overweight and Obesity; Behavior, Eating
• Interventions: Behavioral: Control Group (CG); Behavioral: Intervention Group (IG)

• Registration Number: NCT04032249
• Lead Sponsor: Universidad de Córdoba

Brief Summary

This study aims to analyze the effectiveness of introducing behavioral elements in a weight loss program, in this case, comparing the difference between self-weighing versus not doing so.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-12-15
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Last Update Submitted: 2019-07-22
• Study First Posted: 2019-07-25
• Last Update Posted: 2019-07-25
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• Having a IMC >25,
• Being sedentary and
• Have not been submitted to a restrictive diet in the 6 months preceding this study

Exclusion Criteria

• Suffered from type 2 diabetes or renal conditions
• Being pregnancy or attempt at pregnancy,
• Undergoing antidepressant pharmacological treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (CG)	Control Group (CG)	Education and modifying diet
Intervention Group (IG)	Intervention Group (IG)	Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week

Primary Outcome Measures

Name	Time	Method
Changes from baseline BMI	At baseline (0 years) and followed for 2 years	Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale
Changes from baseline Fatty mass	At baseline (0 years) and followed for 2 years	Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Free-fatty mass	At baseline (0 years) and followed for 2 years	Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Muscular Mass	At baseline (0 years) and followed for 2 years	Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Changes from baseline Corporal Water	At baseline (0 years) and followed for 2 years	Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Adherence to dietary pattern will be also measured through personal interview	At baseline (0 years) and followed for 2 years	Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.

Trial Locations

Locations (1)

Universidad de Córdoba; 🇪🇸 Córdoba, Spain