ObesityWLM3PNCT04192357
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
A study testing WLM3P and Low-carb diet in people with Obesity, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- WLM3P and Low-carb diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Mar 2021to Jun 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65 years
- BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
- Interested in being enrolled in a weight loss program
- Available to comply with study protocol and sign informed consent
Who cannot join
- Pregnant, breastfeeding or planning to become pregnant within the study period.
- Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
- Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
- Subjects with renal impairment
- Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
- Subjects with autoimmune diseases and/or chronic use of corticosteroids.
Show all 22Show fewer
- Use of weight loss medications/other nutritional supplements
- Subjects with psychiatric or neurological illness
- Subjects sensitive to any component of supplements
- Subjects with surgery or hospitalization in the last 30 days
- Subjects prescribed with 5 or more drugs
- Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study
- Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)
- Subjects with history of drug, alcohol or other substances abuse.
- Eating behavior disorders
- Pacemaker carrier
- Urinary incontinence
- Vegetarians or vegans
- Subjects underwent bariatric surgery
- Type 1 or type 2 diabetes mellitus
- Altered blood clotting
- Severe heart failure
Trial locations and contacts
1 site in 1 country.
Portugal1 site
NOVA Medical School, NOVA University of Lisbon
Lisbon, 1169-056
About this study
The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.
- Conditions
- Obesity
- Being tested
- WLM3P, Low-carb diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WLM3PBehavioural
18 months behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 month and 5 months, respectively; and a third phase of weight maintenance, during 12 months).
Low-carb dietBehavioural
18 months behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance during 12 months).
| Study group | Role | What they receive |
|---|---|---|
| WLM3P | Experimental | Participants will receive the M3F program. The M3F program is divided into three phases, being the first two of weight loss and the third phase of weight maintenance. Receives: Behavioral: WLM3P |
| Low-carb diet | Active comparator | Participants will receive the low-carb diet program. The low-carb diet program is divided into two phases, being the first of weight loss which follows a low carb diet, and a second phase of weight maintenance. Receives: Behavioral: Low-carb diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
Measured: 18 months
Secondary outcomes (21)
Change in total fat mass
Difference between the intervention and control group in the change of total fat mass, measured by bioimpedance analysis from baseline to the end of follow-up.
Measured: 18 months
Change in waist circumference
Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.
Measured: 18 months
Change in body mass index
Change in body mass index (calculated as change in kg/m2, weight in kilograms, height in meters) from baseline to the end of follow-up.
Measured: 18 months
Change in systolic and diastolic blood pressure
Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.
Measured: 18 months
Change in intestinal microbiota
Difference between the intervention and control group in the change of intestinal microbiota from baseline to the end of follow-up.
Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
Measured: 18 months
Change in fasting plasma glucose concentrations
Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in fasting plasma insulin concentrations
Difference between the intervention and control group in the change of serum insulin concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in fasting plasma triglycerides concentrations
Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in fasting plasma low density lipoprotein (LDL) concentrations
Difference between the intervention and control group in the change of serum low density lipoprotein (LDL) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in fasting plasma high density lipoprotein (HDL) concentrations
Difference between the intervention and control group in the change of serum high density lipoprotein (HDL) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations
Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in alanine aminotransferase (ALT) concentrations
Difference between the intervention and control group in the change of alanine aminotransferase (ALT) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in aspartate aminotransferase (AST) concentrations
Difference between the intervention and control group in the change of aspartate aminotransferase (AST) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in gamma-glutamyl transpeptidase (GGT) concentrations
Difference between the intervention and control group in the change of gamma-glutamyl transpeptidase (GGT) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in HOMA-IR
Difference between the intervention and control group in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to the end of follow-up, calculated using the formula: fasting plasma glucose (mmol/L) x Fasting insulin (mIU/L)/22.5.
Measured: 18 months
Change in creatinine concentrations
Difference between the intervention and control group in the change of creatinine concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in vitamin D concentrations
Difference between the intervention and control group in the change of vitamin D concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in high-sensitivity C-reactive protein (hs-CRP) concentrations
Difference between the intervention and control group in the change of high-sensitivity C-reactive protein (hs-CRP) concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in sodium concentrations
Difference between the intervention and control group in the change of sodium concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in potassium concentrations
Difference between the intervention and control group in the change of potassium concentrations from baseline to the end of follow-up.
Measured: 18 months
Change in magnesium concentrations
Difference between the intervention and control group in the change of magnesium concentrations from baseline to the end of follow-up.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start25 Mar 2021
- Primary completion20 Jan 2023
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
- Responsible party
- Sponsor
- Investigators
- Conceição Calhau, PhD, Principal investigator, CINTESIS, NOVA Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192357
- Sponsor's protocol ID
- WLM3P01
- Acronym
- WLM3P
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira V, Cuevas-Sierra A, de la O V, Salvado R, Barreiros-Mota I, Castela I, Camelo A, Brandao I, Santo CE, Faria A, Calhau C, Silvestre MP, Moreira-Rosario A. Gut Microbiota Shifts After a Weight Loss Program in Adults with Obesity: The WLM3P Study. Nutrients. 2025 Jul 18;17(14):2360. doi: 10.3390/nu17142360.
PubMed 40732984Pereira V, Barreiros-Mota I, Cortez F, Castela I, Teixeira D, Calhau C, Camila Dias C, Moreira-Rosario A, Silvestre MP. A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study. Eur J Clin Nutr. 2024 Aug;78(8):694-702. doi: 10.1038/s41430-024-01454-4. Epub 2024 Jun 6.
PubMed 38844671
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
- ClinicalTrials.gov ID
- NCT04192357
- Acronym / sponsor ID
- WLM3P / WLM3P01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 10 Dec 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.
The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WLM3P | Experimental | Behavioral: WLM3PParticipants will receive the M3F program. The M3F program is divided into three phases, being the first two of weight loss and the third phase of weight maintenance. |
| Low-carb diet | Active comparator | Behavioral: Low-carb dietParticipants will receive the low-carb diet program. The low-carb diet program is divided into two phases, being the first of weight loss which follows a low carb diet, and a second phase of weight maintenance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 to 65 years
- BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
- Interested in being enrolled in a weight loss program
- Available to comply with study protocol and sign informed consent
Key exclusion criteria (22 listed)
- Pregnant, breastfeeding or planning to become pregnant within the study period.
- Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
- Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
- Subjects with renal impairment
- Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
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 |
|---|---|---|
| WLM3P18 months behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 month and 5 months, respectively; and a third phase of weight maintenance, during 12 months). | Behavioural | WLM3P |
| Low-carb diet18 months behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance during 12 months). | Behavioural | Low-carb diet |
Primary outcome
Change in weight
Time frame: 18 months
Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.
21 secondary outcomes
Change in total fat mass
Time frame: 18 months
Change in waist circumference
Time frame: 18 months
Change in body mass index
Time frame: 18 months
Change in systolic and diastolic blood pressure
Time frame: 18 months
Change in intestinal microbiota
Time frame: 18 months
Change in fasting plasma glucose concentrations
Time frame: 18 months
Change in fasting plasma insulin concentrations
Time frame: 18 months
Change in fasting plasma triglycerides concentrations
Time frame: 18 months
Change in fasting plasma low density lipoprotein (LDL) concentrations
Time frame: 18 months
Change in fasting plasma high density lipoprotein (HDL) concentrations
Time frame: 18 months
Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations
Time frame: 18 months
Change in alanine aminotransferase (ALT) concentrations
Time frame: 18 months
Change in aspartate aminotransferase (AST) concentrations
Time frame: 18 months
Change in gamma-glutamyl transpeptidase (GGT) concentrations
Time frame: 18 months
Change in HOMA-IR
Time frame: 18 months
Change in creatinine concentrations
Time frame: 18 months
Change in vitamin D concentrations
Time frame: 18 months
Change in high-sensitivity C-reactive protein (hs-CRP) concentrations
Time frame: 18 months
Change in sodium concentrations
Time frame: 18 months
Change in potassium concentrations
Time frame: 18 months
Change in magnesium concentrations
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40732984Pereira V, Cuevas-Sierra A, de la O V, Salvado R, Barreiros-Mota I, Castela I, Camelo A, Brandao I, Santo CE, Faria A, Calhau C, Silvestre MP, Moreira-Rosario A. Gut Microbiota Shifts After a Weight Loss Program in Adults with Obesity: The WLM3P Study. Nutrients. 2025 Jul 18;17(14):2360. doi: 10.3390/nu17142360.
- Derived from this study: PubMed 38844671Pereira V, Barreiros-Mota I, Cortez F, Castela I, Teixeira D, Calhau C, Camila Dias C, Moreira-Rosario A, Silvestre MP. A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study. Eur J Clin Nutr. 2024 Aug;78(8):694-702. doi: 10.1038/s41430-024-01454-4. Epub 2024 Jun 6.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
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.
Conceição Calhau, PhD principal investigator
CINTESIS, NOVA Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WLM3P and Low-carb diet in people with Obesity, run by Universidade do Porto at 1 site in Portugal.
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 4 inclusion and 22 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 8 Feb 2023. 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 Portugal. 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?
Change in weight (time frame: 18 months). 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 NCT04192357, which also lists 2 linked publications.
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 8 Feb 2023.