An interventional study of Intervention-Nutrition guidelines and Nutrition guidelines in Overweight and Obesity, Vitamin A Deficiency and Dietary Modification, sponsored by Universidad de Sonora. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Universidad de Sonora · Not applicable, Interventional, and Treatment
Among 212 studies in Obesity with a site in Mexico — 42 open to participants now, 61 under way, 29 of them phase 3. Obesity · Mexico.
Among the 212 studies in Obesity with a site in Mexico, this one is the 163rd largest by enrollment of the 190 interventional ones that give a count, is one of 19 that started in 2018, is one of 99 with no phase, and was the 75th registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →42 of the 212 studies in Obesity with a site in Mexico are open now. Recruiting first, the newest first:
Anahuac University · Sites in Mexico
Ages 30–40
Eli Lilly and Company · Sites in Mexico, United States, Belgium and 7 more countries
Ages 6–11
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Sites in Mexico
Ages 18+
Pfizer · Sites in Mexico, United States, Brazil and 8 more countries
Ages 18+
Novo Nordisk A/S · Sites in Mexico, United States, Argentina and 24 more countries
Ages 18+
A study can be open while its sites in Mexico have not opened yet or have stopped. Only those recruiting at a site in Mexico →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 18 Years to 40 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
212 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 17 · Phase 3 55 · Phase 4 15
First in 2005; this study’s year is marked. 19 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 104 across the 190 interventional studies, 60 across the 21 observational. Of the 114 that completed or were terminated, 17 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
77 of 212 have an industry lead sponsor. The 10 most frequent:
Universidad de Sonora is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Universidad de Sonora has 8 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
13 of the studies in Obesity with a site in Mexico that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06672549Phase 3Eli Lilly and CompanyA Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) | 2027-02 |
| NCT05556512Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity | 2027-10 |
| NCT06439277Phase 3Eli Lilly and CompanyA Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) | 2027-10 |
Add all 13 to your calendar (.ics) → With an account.
Among the 212 studies in Obesity with a site in Mexico, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.
This protocol was approved by the Bioethics Committee of the Department of Medicine and Health Sciences of Universidad de Sonora. A randomized controlled trial will be carried out and participant women will be assigned by simple randomization 1:1 to either the intervention or control group, upon signing an informed consent. At baseline (2wk postpartum), anthropometric (weight, height, mid upper-arm circumference and triceps skinfold thickness) and body composition (DXA) measurements as well as the assessment of vitamin A status (serum and breastmilk retinol and the modified relative dose response) will be performed. The control group will receive only recommendations for a healthy diet in accordance with international standards and will be followed up every month to promote adherence and to assess their nutritional status. On the other hand, the intervention group will receive an individualized macronutrient meal equivalent menu, with nutritional consultations every two weeks. The dietary plan will include 1-1.5 g/kg body weight protein, 30% total fat (preferably mono and polyunsaturated fatty acids), and vitamin A sources (1300 RAE). After 3 months of intervention are completed, baseline measurements will be repeated. Statistical analysis will include descriptive stats and comparisons between groups (t-tests), significance will be defined as P \< 0.05.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
This study's enrollment of 30 is below the median of 67 across 9,010 interventional studies indexed under Obesity.
Browse Obesity studies →Universidad de Sonora is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.
Behavioral: Intervention-Nutrition guidelines
Participants will receive general nutritional recommendations according to international standards
Behavioral: Nutrition guidelines
Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.
Nutritional recommendations based on international guidelines
Total Body weight
Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively
Time frame: Baseline and 3 months after enrollment
Vitamin A liver stores
Stores are calculated as the DR/R ratio. The outcome will be calculated as the difference in change (between baseline and final VA stores within groups) between the intervention and control group, respectively
Time frame: Baseline and 3 months after enrollment
Body fat mass
Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively
Time frame: Baseline and 3 months after enrollment
Retinol
Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively
Time frame: Baseline and 3 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Feb 2020, 15 months.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 15 months is below that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Universidad de Sonora