Clinical Trials Directory

Trials / Completed

CompletedNCT03400696

Web-based Weight Loss Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63,656 (actual)
Sponsor
23andMe, Inc. · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLower carbohydrate dietFocused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
BEHAVIORALHigher fiber dietFocused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
BEHAVIORALPhysical activity focusedFocused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>

Timeline

Start date
2017-12-27
Primary completion
2019-01-08
Completion
2019-04-16
First posted
2018-01-17
Last updated
2020-06-04

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03400696. Inclusion in this directory is not an endorsement.