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OpenTrials
Completed

NCT Number: NCT03400696

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

23andMe, Mountain View, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower carbohydrate diet

Behavioral

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

Higher fiber diet

Behavioral

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

Physical activity focused

Behavioral

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

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Change in waist circumference from week 1 to week 12 of intervention

    Time frame: 12 weeks

  2. Change in waist-to-hip ratio from week 1 to week 12 of intervention

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

23andMe, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2018
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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