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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized- Lower carbohydrate diet | Experimental |
| |
| Randomized- Higher fiber diet | Experimental |
| |
| Randomized- Exercise focused | Experimental |
| |
| Participant chooses- Lower carbohydrate diet | Experimental |
| |
| Participant chooses- Higher fiber diet | Experimental |
| |
| Participant chooses- Exercise focused | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower carbohydrate diet | Behavioral | Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight from week 1 to week 12 of intervention | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Benton, PhD | 23andMe, Inc. | Principal Investigator |
| Liana Del Gobbo, PhD | 23andMe, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 23andMe | Mountain View | California | 94041 | United States | ||
| 23andMe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26253612 | Background | Papandonatos GD, Pan Q, Pajewski NM, Delahanty LM, Peter I, Erar B, Ahmad S, Harden M, Chen L, Fontanillas P; GIANT Consortium; Wagenknecht LE, Kahn SE, Wing RR, Jablonski KA, Huggins GS, Knowler WC, Florez JC, McCaffery JM, Franks PW; Diabetes Prevention Program and the Look AHEAD Research Groups. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials. Diabetes. 2015 Dec;64(12):4312-21. doi: 10.2337/db15-0441. Epub 2015 Aug 7. | |
| 26692578 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
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| Higher fiber diet | Behavioral | Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity |
|
| Physical activity focused | Behavioral | Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov\> [blocked] |
|
| Mountain View |
| California |
| 94043 |
| United States |
| Background |
| Bray MS, Loos RJ, McCaffery JM, Ling C, Franks PW, Weinstock GM, Snyder MP, Vassy JL, Agurs-Collins T; Conference Working Group. NIH working group report-using genomic information to guide weight management: From universal to precision treatment. Obesity (Silver Spring). 2016 Jan;24(1):14-22. doi: 10.1002/oby.21381. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |