Overweight and ObesityNCT04032249
Implications of Self-weighing During Weight Loss Treatment
A study testing Intervention Group (IG) in people with Overweight and Obesity and Signs and Symptoms, run by Universidad de Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Signs and Symptoms, Behavior, Eating
- What is being tested?
- Intervention Group (IG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a IMC >25,
- Being sedentary and
- Have not been submitted to a restrictive diet in the 6 months preceding this study
Who cannot join
- Suffered from type 2 diabetes or renal conditions
- Being pregnancy or attempt at pregnancy,
- Undergoing antidepressant pharmacological treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial
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.
- Conditions
- Overweight and Obesity, Signs and Symptoms, Behavior, Eating
- Being tested
- Control Group (CG), Intervention Group (IG)
- Keywords
- Obesity, Self-weighing, Weight loss, Mobile health
- Medical subject headings
- Overweight, Obesity, Signs and Symptoms, Feeding Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group (CG)Behavioural
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 Group (IG)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | Active comparator | Education and modifying diet Receives: Behavioral: Control Group (CG) |
| Intervention Group (IG) | Experimental | Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week Receives: Behavioral: Intervention Group (IG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline (0 years) and followed for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Feb 2018
- Primary completion15 Dec 2018
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Hernández de los Reyes, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032249
- Sponsor's protocol ID
- P5_A284R4156
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32210897
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial
- ClinicalTrials.gov ID
- NCT04032249
- Acronym / sponsor ID
- P5_A284R4156
- Conditions
- Overweight and Obesity, Signs and Symptoms, Behavior, Eating
- Keywords
- Obesity, Self-weighing, Weight loss, Mobile health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | Active comparator | Behavioral: Control Group (CG)Education and modifying diet |
| Intervention Group (IG) | Experimental | Behavioral: Intervention Group (IG)Education, modifying diet and Indications to record self-weighing with a frequency of 2 times per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a IMC >25,
- Being sedentary and
- Have not been submitted to a restrictive diet in the 6 months preceding this study
Key exclusion criteria (3 listed)
- Suffered from type 2 diabetes or renal conditions
- Being pregnancy or attempt at pregnancy,
- Undergoing antidepressant pharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Control Group (CG) |
| 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 | Behavioural | Intervention Group (IG) |
Primary outcome
Changes from baseline BMI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 32210897Hernandez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (IG) in people with Overweight and Obesity and Signs and Symptoms, run by Universidad de Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline BMI (time frame: At baseline (0 years) and followed for 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.