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OpenTrials
Completed

NCT Number: NCT04514679

EHR Embedded Comparative Effectiveness Studies--WWC

Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

About this study

EHR Embedded Comparative Effectiveness Studies-WWC will be held in the Weight and Wellness Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Adults (>18) able to consent, with sufficient fluency in English; Initial RD and HC visits are part of routine care as recommended by the provider; willing to be randomized

Exclusion criteria

Pregnant women; Prisoners; Children (<18)

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Treatment and study plan

Dietician / Health Coach

Behavioral

The order of visit for the two types of providers is first Dietician then Health Coach.

Health Coach / Dietician

Behavioral

The order of visit for the two types of providers is first Health Coach then Dietician.

Primary outcomes

  1. Compliance Rate

    Time frame: Baseline through approximately 2 months

    Percentage of those in each arm who complete the two visits in the correct order assigned.

  2. Percentage of Eligible Patients Participating

    Time frame: One day, during the recruitment period of October 23, 2020 to February 3, 2021.

    Percentage of those identified as being eligible who were enrolled in the study.

Secondary outcomes

  1. Change in Body Mass Index (BMI) at 30 Days

    Time frame: 30 days since baseline

    Linear trends (or "slopes") for per 30 days are calculated in each group. The slopes were calculated from repeated BMI measurements in each treatment group, and expressed in terms of the change in BMI predicted at 30 days post randomization.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • Trustees of Dartmouth College

Registry information

Official study title

Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems

Acronym: EHR-WWC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2020
Registry last updated
Jun 12, 2025

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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