NCT04899648

Brief Summary

This is an effectiveness-implementation study to assess the effectiveness of a peer-led multi-component lifestyle program that will aim to lower BP among pre-hypertensive individuals in Nepal. The program will aim to encourage weight loss, improve diet (using a DASH diet), lower sodium intake, encourage only moderate alcohol intake among drinkers, and encourage more physical activity through peers.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable hypertension

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

May 19, 2021

Last Update Submit

May 23, 2021

Conditions

HypertensionDietary ModificationHealth Behavior

Keywords

Hypertension Prevention

Outcome Measures

Primary Outcomes (2)

  • Systolic Blood pressure

    An average of three measurements, mmHg continuous variable

    Four months

  • Diastolic Blood pressure

    An average of three measurements, mmHg continuous variable

    Four months

Secondary Outcomes (2)

  • Body Mass Index

    Four Months

  • Healthy food intake

    Four Months

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

Receives nutrition and exercise intervention classes

Behavioral: Behavioral Intervention Group

Control Group

NO INTERVENTION

Does not receive any intervention classes

Interventions

Behavioral Intervention GroupBEHAVIORAL

Behavioral intervention: (a) form groups and choose peer leaders; (b) train peer leaders on 16 core classes based on diabetes prevention program curriculum; (c) support and motivate peer leaders to lead intervention in their group; (d) monitoring of the interventions.

Behavioral Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Full-time employees who work a minimum of 40 hours per week as appointed by the school within the age group of 18-60 including both male and female.

You may not qualify if:

  • Pregnant females, Participants below 18 years or and above 60.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionHealth Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Bhawana Shrestha, MPH, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Dettinger, MPH

CONTACT

206-221-1041jcdettin@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

May 30, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05