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Clinical Trials/NCT03400696
NCT03400696
Completed
Not Applicable

Web-based Weight Loss Intervention

23andMe, Inc.1 site in 1 country63,656 target enrollmentDecember 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
23andMe, Inc.
Enrollment
63656
Locations
1
Primary Endpoint
Change in weight from week 1 to week 12 of intervention
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 27, 2017
End Date
April 16, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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(12 weeks)
  • Change in waist-to-hip ratio from week 1 to week 12 of intervention(12 weeks)

Study Sites (1)

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