Web-based Weight Loss Intervention

NCT03400696 | Completed DMC

• 1 other identifier: 23andMe_WLI001
• Study Type: interventional
• Target: 63,656
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Keywords

nutrition, diet, genetics, physical activity, weight loss

Outcome Measures

Primary Outcomes (1)

• Change in weight from week 1 to week 12 of intervention

  12 weeks

Secondary Outcomes (2)

• 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

Study Arms (6)

Randomized- Lower carbohydrate diet

EXPERIMENTAL

Behavioral: Lower carbohydrate diet

Randomized- Higher fiber diet

EXPERIMENTAL

Behavioral: Higher fiber diet

Randomized- Exercise focused

EXPERIMENTAL

Behavioral: Physical activity focused

Participant chooses- Lower carbohydrate diet

EXPERIMENTAL

Behavioral: Lower carbohydrate diet

Participant chooses- Higher fiber diet

EXPERIMENTAL

Behavioral: Higher fiber diet

Participant chooses- Exercise focused

EXPERIMENTAL

Behavioral: Physical activity focused

Interventions

Lower carbohydrate diet BEHAVIORAL

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

Participant chooses- Lower carbohydrate diet; Randomized- Lower carbohydrate diet

Higher fiber diet BEHAVIORAL

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

Participant chooses- Higher fiber diet; Randomized- Higher fiber diet

Physical activity focused BEHAVIORAL

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

Participant chooses- Exercise focused; Randomized- Exercise focused

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 23andMe, Inc.: lead

Study Sites (2)

23andMe

Mountain View, California, 94041, United States

Location

23andMe

Mountain View, California, 94043, United States

Location

Related Publications (2)

• 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.

  PMID: 26253612 BACKGROUND

• 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.

  PMID: 26692578 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Study Officials

• Geoffrey Benton, PhD

  23andMe, Inc.

  PRINCIPAL INVESTIGATOR

• Liana Del Gobbo, PhD

  23andMe, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 17, 2018
• Study Start: December 27, 2017
• Primary Completion: January 8, 2019
• Study Completion: April 16, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)