Implications of Self-weighing During Weight Loss Treatment

• Sponsor: Universidad de Córdoba (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04032249
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Signs and Symptoms; Behavior, Eating	Behavioral: Control Group (CG); Behavioral: Intervention Group (IG)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Dec 15, 2018
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group (CG) Education and modifying diet	Behavioral: Control Group (CG); 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
Experimental: Intervention Group (IG) Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week	Behavioral: Intervention Group (IG); 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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Córdoba	Córdoba		Spain	14014

Sponsors and Collaborators

• Universidad de Córdoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alberto Hernández de los Reyes, Principal Investigator, Universidad de Córdoba
• ClinicalTrials.gov Identifier: NCT04032249
• Other Study ID Numbers: P5_A284R4156
• First Posted: Jul 25, 2019
• Last Update Posted: Jul 25, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alberto Hernández de los Reyes, Principal Investigator, Universidad de Córdoba: Obesity; Self-weighing; Weight loss; Mobile health
• Additional relevant MeSH terms: Overweight; Weight Loss; Body Weight

Study Results

No Results Posted as of Jul 25, 2019