Web-based Weight Loss Intervention

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Lower carbohydrate diet; Behavioral: Higher fiber diet; Behavioral: Physical activity focused

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 Type: Interventional
• Enrollment (Actual): 63656
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94041
      • 23andMe
    • Mountain View, California, United States, 94043
      • 23andMe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized- Lower carbohydrate diet	Behavioral: Lower carbohydrate diet; Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
Experimental: Randomized- Higher fiber diet	Behavioral: Higher fiber diet; Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
Experimental: Randomized- Exercise focused	Behavioral: Physical activity focused; Focused on aerobic and resistance exercise, while following dietary guidelines
Experimental: Participant chooses- Lower carbohydrate diet	Behavioral: Lower carbohydrate diet; Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
Experimental: Participant chooses- Higher fiber diet	Behavioral: Higher fiber diet; Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
Experimental: Participant chooses- Exercise focused	Behavioral: Physical activity focused; Focused on aerobic and resistance exercise, while following dietary guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight from week 1 to week 12 of intervention	12 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: 23andMe, Inc.
• Investigators: Principal Investigator: Geoffrey Benton, PhD, 23andMe, Inc.; Study Director: Liana Del Gobbo, PhD, 23andMe, Inc.

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Obesity (Silver Spring). 2016 Mar;24(3):757.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2017
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: nutrition, diet, genetics, physical activity, weight loss
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 23andMe_WLI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No