Back to resultsImplications of Self-weighing During Weight Loss Treatment
Primary Purpose
Overweight and Obesity, Signs and Symptoms, Behavior, Eating
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control Group (CG)
Intervention Group (IG)
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Obesity, Self-weighing, Weight loss, Mobile health
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
Sites / Locations
- Universidad de Córdoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group (CG)
Intervention Group (IG)
Arm Description
Education and modifying diet
Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week
Outcomes
Primary Outcome Measures
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
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04032249
Brief Title
Implications of Self-weighing During Weight Loss Treatment
Official Title
Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Signs and Symptoms, Behavior, Eating
Keywords
Obesity, Self-weighing, Weight loss, Mobile health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CG)
Arm Type
Active Comparator
Arm Description
Education and modifying diet
Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week
Intervention Type
Behavioral
Intervention Name(s)
Control Group (CG)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (IG)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes from baseline BMI
Description
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
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Fatty mass
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Free-fatty mass
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Muscular Mass
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Corporal Water
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to dietary pattern will be also measured through personal interview
Description
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.
Time Frame
At baseline (0 years) and followed for 2 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
the present study is carried out in men
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universidad de Córdoba
City
Córdoba
ZIP/Postal Code
14014
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32210897
Citation
Hernandez-Reyes A, Camara-Martos F, Vidal A, Molina-Luque R, Moreno-Rojas R. Effects of Self-Weighing During Weight Loss Treatment: A 6-Month Randomized Controlled Trial. Front Psychol. 2020 Mar 10;11:397. doi: 10.3389/fpsyg.2020.00397. eCollection 2020.
Results Reference
derived
Learn more about this trial
Implications of Self-weighing During Weight Loss Treatment
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