Brief Summary

The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants. LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design. Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a shelter of Functional Medicine interventions against the storm of chronic disease. Under this Tent are a collection of Umbrellas where participants with similar clinical challenges are evaluated as clinically defined groups with loose guidelines for the planned interventions. Finally, participants standing under these Umbrellas may step into specific Buckets that gather individuals with nearly identical clinical presentations into more formally described prescriptive randomized arms for intervention. Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

September 1, 2018

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2019

Completed

17 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed

Last Updated

October 30, 2023

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

June 15, 2019

Last Update Submit

October 26, 2023

Conditions

Health, Subjective Gastrointestinal Dysfunction Cardiovascular Risk Factor Autoimmune Diseases Dental Diseases Hormone Disturbance Neurocognitive Dysfunction

Keywords

wellnessn-of-1 trialdetoxificationpersonalized medicinefunctional medicine4P medicinelifestyle medicinehomocysteinedietary supplementmedical foodbehavioral changelifestyle modificationemployee wellness programfunctional capacityfood plan

Outcome Measures

Primary Outcomes (3)

Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire
The MOS SF-36 is an indicator of overall health status. It has an eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability.
Change from baseline at 12 months
University of Rhode Island Change Assessment (URICA) questionnaire
URICA questionnaire is a 32 item self-report measure that includes 4 subscales measuring the stages of change: Precontemplation, Contemplation, Action, and Maintenance (there is also a 24 item version). Responses are given on a 5 point Likert scale ranging from (1=strong disagreement to 5=strong agreement),
Change from baseline at 12 months
Depression Anxiety, Stress Scale (DASS) questionnaire
The Depression, Anxiety and Stress Scale is a 21 items questionnaire that includes a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Outcome is divided into normal, mild, moderate, severe, and very severe for each of the 3 categories: Depression, Anxiety, and Stress. A low score represents the normal and the higher the score the more severe the outcome.
Change from baseline at 12 months

Secondary Outcomes (18)

Body Mass Index (BMI)
Change from baseline at 12 months
Waist Circumference (WC)
Change from baseline at 12 months
Hip Circumference (HC)
Change from baseline at12 months
Waist to Hip Ratio (WHR)
Change from baseline at 12 months
Height
Change from baseline at 12 months
+13 more secondary outcomes

Study Arms (21)

N of 1 Tent

OTHER

Personalized dietary supplements, food plans, and behavioral change support program for a broad group (both an employee population and those recruited from practitioner practices) inclusive of all study Participants and specifically generally healthy individuals, those with established disease/conditions requiring a personalized approach, those with diseases/conditions currently with low prevalence in our study population and those women currently pregnant or breastfeeding.