Implications of Self-weighing During Weight Loss Treatment
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedFirst Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 25, 2019
July 1, 2019
11 months
July 22, 2019
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (2)
Control Group (CG)
ACTIVE COMPARATOREducation and modifying diet
Intervention Group (IG)
EXPERIMENTALEducation, modifying diet and Indications to record self-weighing with a frequency of 2 times per week
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Having a IMC \>25,
- Being sedentary and
- Have not been submitted to a restrictive diet in the 6 months preceding this study
You may not qualify if:
- Suffered from type 2 diabetes or renal conditions
- Being pregnancy or attempt at pregnancy,
- Undergoing antidepressant pharmacological treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Córdoba
Córdoba, 14014, Spain
Related Publications (1)
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.
PMID: 32210897DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 22, 2019
First Posted
July 25, 2019
Study Start
February 1, 2018
Primary Completion
December 15, 2018
Study Completion
June 1, 2020
Last Updated
July 25, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share