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

NCT03629301 | Completed

• 1 other identifier: USO313003634
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity or Overweight

Keywords

Obesity; Overweight; Lifestyle Intervention; Randomized controlled Trial; Internet delivered; Online; Weight loss

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  baseline to 3 months

Secondary Outcomes (14)

• 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

Study Arms (2)

ID-DPP group

EXPERIMENTAL

Internet-delivered intervention based on the DPP

Behavioral: ID-DPP group

Wait-list Group

OTHER

Other: Wait-list Group

Interventions

ID-DPP group BEHAVIORAL

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.

ID-DPP group

Wait-list Group OTHER

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.

Wait-list Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (1)

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 36694376 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 14, 2018
• Study Start: September 17, 2018
• Primary Completion: July 31, 2019
• Study Completion: October 30, 2019
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

ME (1)