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Obesity or OverweightDPPON-MEXNCT03629301

Obesity Treatment Using an Internet-delivered Intervention Based on the Diabetes Prevention Program in Mexican Adults

A study testing ID-DPP group and Wait-list Group in people with Obesity or Overweight, run by Universidad de Sonora at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In Mexico, 7 out of 10 adults are overweight or obese. The diseases associated with these conditions (diabetes, cardiovascular disease and some cancers) are those that impact the most on the disability-adjusted life years of Mexicans and on their mortality rates. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity or Overweight
What is being tested?
ID-DPP group and Wait-list Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteMexico
Study dates
17 Sep 2018to 30 Oct 2019
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Mexican adults (≥ 18 years and ≤60)
  • Residents of the city of Hermosillo, Sonora
  • Overweight or obese (BMI ≥ 25 and ≤45)
  • Internet access at home
  • Basic computer skills
  • Facebook active account
  • Candidates must make records of their food consumption for 5 days.

Who cannot join

  • Substance abuse
  • Consumption of more than 14 alcoholic beverages per week (equivalent to 280 g of alcohol)
  • Diagnosis of psychiatric conditions that could prevent adherence to treatment
  • Previous diagnosis of medical conditions with significant effect on body weight
  • Diagnosis of diabetes
  • Systolic blood pressure> 160 mm / Hg
Show all 16Show fewer
  • Pregnant women who are breastfeeding or who plan to become pregnant during the study period
  • Consumption of medications with an effect on body weight such as metformin, orlistat or glucocorticoids.
  • Participating in another program to reduce weight or performing structured physical exercise other than walking> 180 min / week
  • Plan to participate in some treatment for weight loss during the study
  • Any other condition in which weight loss or physical activity is contraindicated
  • Previous diagnosis of kidney failure, cancer or any other condition that requires special treatment
  • Relatives participating in the study
  • Have plans to change residence
  • Criteria of the researcher - for clinical reasons or adherence to the protocol
  • Weight loss>5% of total body weight in the previous 4 months

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro de Promoción de Salud Nutricional (CPSN)

    Hermosillo, Sonora, 83000

Other trials in Mexico

About this study

Official title: Efficacy of an Internet-delivered Intervention Based on the Diabetes Prevention Program for Weight Loss in Overweight and Obese Mexican Adults: 3 and 6 Months Randomized Controlled Trial

In Mexico, 7 out of 10 adults are overweight or obese. The diseases associated with these conditions (diabetes, cardiovascular disease and some cancers) are those that impact the most on the disability-adjusted life years of Mexicans and on their mortality rates. A reduction in body weight of 5-10% can reduce the incidence of obesity related diseases. The gold standard for treating obesity is an intensive lifestyle change program such as the Diabetes Prevention Program (DPP) whose effectiveness has been evaluated in various formats and populations with positive results, including in Mexico. However, the DPP is not accessible to all sectors of the population. To increase its dissemination, the implementation of online interventions based on the DPP (oi-DPP) has been proposed. A systematic review of oi-DPP showed promising results, however, the evidence is limited and the lack of studies of high methodological quality is highlighted. The main objective of this project is to evaluate the efficacy of an oi-DPP for weight loss in Mexican adults with overweight or obesity at 3 months. The study design is a randomized controlled trial with 2 arms: oi-DPP and wait-list control. A 3 months pilot study (n=30) will be conducted prior to the main study to estimate sample size, considering an alpha error of 0.05 and power of 80%. The primary outcome is the mean change in body weight from baseline to 3 months post-baseline between the 2 groups. Secondarily, differences in biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides and gamma glutamyl transferase) from baseline to 3 months will be evaluated, as well as mean changes from baseline to 3 and 6 months in body mass index, waist circumference, systolic and diastolic blood pressure, depression and quality of life scales and the number of participants achieving a weight loss greater than 5% of initial body weight. Body weight will be also evaluated at 6 months post-baseline. The previous measurements will apply both in the pilot study and the study except for the biochemical parameters that will only be included in the main study. The differences between the 2 groups for each variable will be analyzed using a t test for independent samples, in case of having a parametric sample. Otherwise, the Mann-Whitney U test will be used. Analysis will follow the intent-to-treat principle.

Being tested
ID-DPP group, Wait-list Group
Keywords
Obesity, Overweight, Lifestyle Intervention, Randomized controlled Trial, Internet delivered, Online, Weight loss
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ID-DPP groupBehavioural

    This group will receive a 6 month long online behavioral change protocol adapted from the Diabetes Prevention Program. It includes 18 sessions, 12 delivered weekly (during the first 3 months) and 6 delivered biweekly (during the last 3 month period). A web page will be used to deliver the sessions, while the nutritional counseling will be delivered using video calls via Facebook chat. Participants will receive an hypocaloric (1200-1800 kcal, carbohydrates: 45-65%, fats: 20-35% and protein: 10-35%), personalized diet.

  • Wait-list GroupOther

    This group will only receive written information with recommendations on healthy eating. When the study has finished this group will receive a behavioral change protocol with nutritional counseling using a face-to-face format.

Study groups in NCT03629301
Study groupRoleWhat they receive
ID-DPP groupExperimentalInternet-delivered intervention based on the DPP
Receives: Behavioral: ID-DPP group
Wait-list GroupOtherNot described
Receives: Other: Wait-list Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Measured: baseline to 3 months

Secondary outcomes (14)

  1. Change in body weight

    Measured: baseline to 6 months

  2. Change in body mass index

    Measured: baseline to 3 months and baseline to 6 months

  3. Change in waist circumference

    Measured: baseline to 3 months and baseline to 6 months

  4. Change in body fat percentage

    Measured: baseline to 3 months and baseline to 6 months

  5. Change in the Beck Depression Inventory Scale

    The Beck Depression Inventory (BDI) is a 21-item questionnaire that assesses mood over the previous week. Total scores range from 0 to 63, with higher values indicating more severe symptoms of depression. Scores of 0-9 reflect minimal (subclinical) symptoms, values of 10-18, 19-29, and ≥30 indicate mild, moderate, and severe symptoms of depression, respectively.

    Measured: baseline to 3 months and baseline to 6 months

  6. Change in the Short Form-36 Health Survey Score

    The SF-36 Health Survey evaluates aspects of quality of life in adult populations (over 16 years of age). The result of its application is the generation of eight concepts or scales of health, which is the result of the average of the sum of all questions contained in the questionnaire for each concept. These eight concepts are: physical function, physical role, corporal pain, general health, vitality, social function, emotional role and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answer to each question is coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, with lower scores indicating poorer health and higher scores better health.

    Measured: baseline to 3 months and baseline to 6 months

  7. Change in systolic and diastolic blood pressure

    Measured: baseline to 3 months and baseline to 6 months

  8. Change in fasting glucose

    Measured: baseline to 3 months

  9. Change in total cholesterol

    Measured: baseline to 3 months

  10. Change in LDL-cholesterol

    Measured: baseline to 3 months

  11. Change in HDL-cholesterol

    Measured: baseline to 3 months

  12. Change in triglycerides

    Measured: baseline to 3 months

  13. Change in gamma glutamyl transferase

    Measured: baseline to 3 months

  14. Number of participants achieving 5% of weight loss

    Measured: baseline to 3 months and baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2018
  2. Study start17 Sep 2018
  3. Primary completion31 Jul 2019
  4. Study completion30 Oct 2019

Resources

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
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03629301
Sponsor's protocol ID
USO313003634
Acronym
DPPON-MEX
Status last verified
Apr 2021
First submitted
10 Aug 2018
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ruelas AL, Martinez Contreras TJ, Esparza Romero J, Diaz Zavala RG, Candia Plata MDC, Hingle M, Armenta Guirado B, Haby MM. Factors influencing adults to drop out of intensive lifestyle interventions for weight loss. Transl Behav Med. 2023 Apr 15;13(4):245-254. doi: 10.1093/tbm/ibac112.

    PubMed 36694376

Questions about this trial

What is this clinical trial studying?

A study testing ID-DPP group and Wait-list Group in people with Obesity or Overweight, run by Universidad de Sonora at 1 site in Mexico.

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 7 inclusion and 16 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: finished, as of the sponsor's last update on 28 Apr 2021. 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 body weight (time frame: baseline to 3 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 NCT03629301, 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 28 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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