An interventional study of Lower carbohydrate diet and Higher fiber diet in Overweight and Obesity, sponsored by 23andMe, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by 23andMe, Inc. · Not applicable, Interventional, and Other
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 63,656 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →23andMe, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Lower carbohydrate diet
Behavioral: Higher fiber diet
Behavioral: Physical activity focused
Behavioral: Lower carbohydrate diet
Behavioral: Higher fiber diet
Behavioral: Physical activity focused
Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
Focused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>
Change in weight from week 1 to week 12 of intervention
Time frame: 12 weeks
Change in waist circumference from week 1 to week 12 of intervention
Time frame: 12 weeks
Change in waist-to-hip ratio from week 1 to week 12 of intervention
Time frame: 12 weeks
Plan to share: No
Ran from Dec 2017 to primary completion in Jan 2019, 12 months.
Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 12 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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23andMe, Inc.