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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID-DPP group | Experimental | Internet-delivered intervention based on the DPP |
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| Wait-list Group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Promoción de Salud Nutricional (CPSN) | Hermosillo | Sonora | 83000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36694376 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| 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. |
|
| 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 | 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. | baseline to 3 months and baseline to 6 months |
| 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. | baseline to 3 months and baseline to 6 months |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |