Web-based Weight Loss Intervention

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Lower carbohydrate diet; Behavioral: Physical activity focused; Behavioral: Higher fiber diet

• Registration Number: NCT03400696
• Lead Sponsor: 23andMe, Inc.

Brief 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.

Study Timeline

• Study Start: 2017-12-27
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Primary Completion: 2019-01-08
• Study Completion: 2019-04-16
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63656

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized- Lower carbohydrate diet	Lower carbohydrate diet	-
Participant chooses- Exercise focused	Physical activity focused	-
Participant chooses- Higher fiber diet	Higher fiber diet	-
Randomized- Higher fiber diet	Higher fiber diet	-
Participant chooses- Lower carbohydrate diet	Lower carbohydrate diet	-
Randomized- Exercise focused	Physical activity focused	-

Primary Outcome Measures

Name	Time	Method
Change in weight from week 1 to week 12 of intervention	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

23andMe; 🇺🇸 Mountain View, California, United States