Web-based Weight Loss Intervention

Study Overview
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Brief Summary
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Excess weight is a major risk factor underlying leading causes of death globally, including cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the same lifestyle intervention arms in prior weight loss randomized controlled trials, large inter-individual differences in weight loss success have been observed, ranging from >50lbs of weight loss to >10lbs of weight gain. Both genetic and non-genetic factors underlying differential adherence and weight loss success are poorly understood.

Detailed Description
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23andMe aims to recruit 91,227 adults to participate in a web-based weight loss intervention. Primary aims include: a.) to confirm whether AG/GG individuals at MTIF3 rs1885988 lose more weight on lifestyle interventions; and b.) to test the performance of a randomized controlled trial vs. self-selection study design in terms of weight loss, drop-outs, and adherence. Secondary (exploratory) analyses will focus on discovery of genetic and non-genetic predictors of weight loss success overall, and examination of potential interactions by intervention type. Web-administered intervention content, videos, and forums will be surfaced to participants every two weeks, and self-reported surveys will be surfaced weekly for the active intervention duration.

Official Title
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Web-based Weight Loss Intervention

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Lower carbohydrate diet
* Behavioral: Higher fiber diet
* Behavioral: Physical activity focused


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US-based men and women in self-reported 'good' or better health Consented to participate in research BMI 25-40 kg/m2 Not actively on a weight loss plan Willing and able to modify eating and physical activity patterns Not under a doctor's care for a serious medical condition Exclusion Criteria: Are pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next 6 months Have diabetes (type 1 or 2) or are on hypoglycemic medications Had a heart attack or stroke within the past year Are unable or unwilling to follow a physical activity or diet intervention due to a medical condition or doctor's orders Have an eating disorder Have severe depression, anxiety, or other psychiatric conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized- Lower carbohydrate diet<br> | Behavioral: Lower carbohydrate diet<br>* Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity<br>|
| Experimental: Randomized- Higher fiber diet<br> | Behavioral: Higher fiber diet<br>* Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity<br>|
| Experimental: Randomized- Exercise focused<br> | Behavioral: Physical activity focused<br>* Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov><br>|
| Experimental: Participant chooses- Lower carbohydrate diet<br> | Behavioral: Lower carbohydrate diet<br>* Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity<br>|
| Experimental: Participant chooses- Higher fiber diet<br> | Behavioral: Higher fiber diet<br>* Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity<br>|
| Experimental: Participant chooses- Exercise focused<br> | Behavioral: Physical activity focused<br>* Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov><br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from week 1 to week 12 of intervention |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference from week 1 to week 12 of intervention |  | 12 weeks | 
| Change in waist-to-hip ratio from week 1 to week 12 of intervention |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, diet, genetics, physical activity, weight loss