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

Sponsor

Universidad de Sonora (Other)

Overall Status

Completed

CT.gov ID

NCT03629301

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity or Overweight	Behavioral: ID-DPP group Other: Wait-list Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 17, 2018

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Oct 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ID-DPP group Internet-delivered intervention based on the DPP	Behavioral: ID-DPP group 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.
Other: Wait-list Group	Other: Wait-list Group 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.

Arm

Intervention/Treatment

Experimental: ID-DPP group

Internet-delivered intervention based on the DPP

Behavioral: ID-DPP group

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.

Other: Wait-list Group

Other: Wait-list Group

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.

Outcome Measures

Primary Outcome Measures

Change in body weight [baseline to 3 months]

Secondary Outcome Measures

Change in body weight [baseline to 6 months]
Change in body mass index [baseline to 3 months and baseline to 6 months]
Change in waist circumference [baseline to 3 months and baseline to 6 months]
Change in body fat percentage [baseline to 3 months and baseline to 6 months]
Change in the Beck Depression Inventory Scale [baseline to 3 months and baseline to 6 months]
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.
Change in the Short Form-36 Health Survey Score [baseline to 3 months and baseline to 6 months]
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.
Change in systolic and diastolic blood pressure [baseline to 3 months and baseline to 6 months]
Change in fasting glucose [baseline to 3 months]
Change in total cholesterol [baseline to 3 months]
Change in LDL-cholesterol [baseline to 3 months]
Change in HDL-cholesterol [baseline to 3 months]
Change in triglycerides [baseline to 3 months]
Change in gamma glutamyl transferase [baseline to 3 months]
Number of participants achieving 5% of weight loss [baseline to 3 months and baseline to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
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