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Due to the retention of 78.1% of the participants obtained for the first measurement (after the December holidays), we believe that waiting one more year to complete the study would not be feasible for a subsequent definitive study.
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Introduction. Obesity is the main risk factor for the development of chronic degenerative diseases in Mexico and other countries around the world. Due to the difficulty of treating obesity, it is necessary to change the curative paradigm for a preventive one. A review showed that holiday periods during the year are critical points for weight gain. The holiday season is the festive period with the greatest impact on adults' body weight. Observational studies have shown that more than 50% of the annual weight is gained during this period. However, few preventive interventions in the festive period have been carried out globally. Additionally, the COVID-19 pandemic seems to be negatively affecting diet, physical activity and body weight. So preventive interventions are needed, especially those that can be implemented in an online format. The purpose of the study is to evaluate the effect of two online interventions -Watch your Weight during the Holidays Program and the Relative 5:2 Fasting - on the prevention of body weight gain from baseline to 8 weeks in comparison with a control group in Mexican adults during the COVID-19 pandemic. Methodology: This is a Pilot Randomized Controlled Trial (RCT). The primary outcome is the change in body weight from baseline to 8 weeks. Secondary outcomes are the percentage of retention / desertion of the participants, adherence to interventions, participant satisfaction scale, changes in other obesity parameters, biochemical, physical, and quality of life variables from baseline to 8 weeks. Obesity and quality of life parameters from baseline to 52 weeks are also secondary outcomes. The statistical analysis of the primary and secondary variables will be conducted, according to their distribution, by intention to treat and, secondarily, by completer´s analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watch your Weight During the Holidays Program | Active Comparator |
| |
| Relative 5:2 Fasting | Active Comparator |
| |
| Control Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watch your Weight During the Holidays Program | Behavioral | Participants in this group will have two video call individual sessions and one video call group session. This intervention will include self-monitoring strategies (self-weighing, diet monitoring and physical activity), and nutrition counseling and education. In addition, participants in this group will receive a weighing scale to achieve self-monitoring of body weight from the beginning of the study intervention until the end of the 52-weeks follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Baseline and 52 weeks | |
| Changes in kilograms of body fat | Baseline, 8 weeks and 52 weeks | |
| Changes in waist circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolando G DÃaz Zavala, Ph.D. | Universidad de Sonora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Promoción de Salud Nutricional (CPSN) | Hermosillo | Sonora | 83000 | Mexico |
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| Relative 5:2 Fasting | Other | Participants in this group will will have two video call individual sessions and one video call group session. This intervention will receive eating recommendations to follow a 5:2 intermittent fasting. They will be given low-calorie menus of 550 kcal and 660 kcal, for women and men respectively, which the participants in this group will apply on fasting days. The fasting will be held twice a week and on the remaining five days, the participants will not have any type of caloric restriction (it will be ad libitum). They will only have the general recommendation to adhere to a healthy dietary pattern. |
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| Control Group | Other | Participants in this group will receive online information and a PDF file brochure during an individual video call session at the beginning of the 8-week period. This information will be about leading a healthy eating based on the norm for health promotion and education for healthy eating in Mexico (NOM-043-SSA2-2012). |
|
| Baseline, 8 weeks and 52 weeks |
| Changes in systolic blood pressure | Baseline, 8 weeks and 52 weeks |
| Changes in diastolic blood pressure | Baseline, 8 weeks and 52 weeks |
| Changes in perception of health related quality of life | The SF-36 Health Survey evaluates aspects of the 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, result of the average of the sum of the questions contained in the questionnaire for each concept. These 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 answers to each question are coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, lower results indicate poorer health and greater result better health. | Baseline, 8 weeks and 52 weeks |
| Retention / desertion | The retention percentage will be obtained by dividing the number of people that finished the intervention the number that started the intervention, multiplied by 100. The dropout percentage will be obtained by the difference in the number of subjects who started and finished the intervention, multiplied by 100. | 8 weeks and 52 weeks |
| Adherence to intervention | Adherence to the intervention will be calculated as the percentage of study measurement appointments and group sessions attended by each participant. Another way to measure adherence to interventions will be with a numerical scale of self-evaluation from 1 to 5, where 1 is the lowest score and 5 is the highest, to indicate how adherent they were to the meal plans. | 8 weeks and 52 weeks |
| Participant satisfaction scale | Satisfaction of the participants in each of the intervention groups will be measured online using a scale from 1 to 5, where 1 is the lowest rating and 5 is the highest. A higher score means a higher satisfaction with the intervention recieved. | 8 weeks and 52 weeks |
| Changes in fasting glucose | Baseline and 8 weeks |
| Changes in total cholesterol | Baseline and 8 weeks |
| Changes in LDL cholesterol | Baseline and 8 weeks |
| Changes in HDL cholesterol | Baseline and 8 weeks |
| Changes in triglycerides | Baseline and 8 weeks |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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