Implications of Self-weighing During Weight Loss Treatment

Study Overview
=================
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.

Official Title
-----------------
Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial

Conditions
-----------------
Behavior, Eating, Overweight and Obesity, Signs and Symptoms

Intervention / Treatment
-----------------
* Behavioral: Control Group (CG)
* Behavioral: Intervention Group (IG)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (CG)<br>Education and modifying diet | Behavioral: Control Group (CG)<br>* The control group is subjected to follow a hypocaloric diet and receives information about the benefits of having healthy habits in relation to decision making and food<br>|
| Experimental: Intervention Group (IG)<br>Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week | Behavioral: Intervention Group (IG)<br>* The control group is subjected to follow a hypocaloric diet and receives information about the benefits of having healthy habits in relation to decision making and food, but also, they will have monitored the self-control of the weight in order to compare the impact of self-weighing versus not doing it<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline BMI | 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 | At baseline (0 years) and followed for 2 years | 
| Changes from baseline Fatty mass | 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. | At baseline (0 years) and followed for 2 years | 
| Changes from baseline Free-fatty mass | 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. | At baseline (0 years) and followed for 2 years | 
| Changes from baseline Muscular Mass | 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. | At baseline (0 years) and followed for 2 years | 
| Changes from baseline Corporal Water | 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. | At baseline (0 years) and followed for 2 years | 
| Adherence to dietary pattern will be also measured through personal interview | 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. | At baseline (0 years) and followed for 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Self-weighing, Weight loss, Mobile health