Web-based Weight Loss Intervention

23andMe, Inc.63,656 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

63,656

Conditions

Overweight and Obesity

Interventions

Lower carbohydrate dietBEHAVIORAL

Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity

Higher fiber dietBEHAVIORAL

Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity

Physical activity focusedBEHAVIORAL

Focused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

23andMe

Mountain View, California, United States

23andMe

Mountain View, California, United States

Outcomes

Primary Outcomes

Change in weight from week 1 to week 12 of intervention

Time frame: 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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