NCT05750407

Brief Summary

The purpose of this pilot study is to examine the feasibility and acceptability of brief lifestyle intervention modules designed to promote healthy eating, activity, and weight control for pregnant and postpartum clients receiving care as part of evidence-based home visiting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

February 20, 2023

Last Update Submit

August 19, 2024

Conditions

Diet, HealthyInactivity, PhysicalObesity

Keywords

home visitingobesitypregnancypostpartumcardiovascular health

Outcome Measures

Primary Outcomes (1)

  • Perceived acceptability of treatment score

    Questionnaire

    6 week

Secondary Outcomes (1)

  • Change in life's essential 8 total score

    6 weeks

Study Arms (1)

Evidence based home visiting with lifestyle modules

EXPERIMENTAL

Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight

Behavioral: Lifestyle change

Interventions

Lifestyle changeBEHAVIORAL

Three modules target healthy eating, activity, and weight control behaviors

Evidence based home visiting with lifestyle modules

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-reported current participation in a home visiting program
  • self-reported currently pregnant or postpartum less than or equal to 6 weeks
  • English or Spanish speaking

You may not qualify if:

  • Age less than 18 years
  • Lower than 5th grade reading level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cal Poly

San Luis Obispo, California, 93407, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Kinesiology & Public Health

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 1, 2023

Study Start

May 15, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)