Obesity Treatment Using an Internet-delivered Intervention Based on the Diabetes Prevention Program in Mexican Adults
Condition: Obesity or Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional

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.
    


Intervention name(s): ID-DPP group; Wait-list Group
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Lifestyle Intervention; Randomized controlled Trial; Internet delivered; Online; Weight loss