NCT03693768

Brief Summary

The purpose of this research study is to determine if a health coaching intervention that includes exercise, good dietary habits, and good relaxation methods helps overweight men improve health and lose weight. The investigator's hope is to enroll 30 men in this research study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration 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

First Submitted

Initial submission to the registry

June 21, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

3.2 years

First QC Date

June 21, 2018

Last Update Submit

June 1, 2022

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity

    Change in weekly physical activity minutes accumulated from baseline measures assessed by employing accelerometry.

    4 months

Secondary Outcomes (2)

  • Change in fruit / vegetable intake

    4 months

  • Change in sleep hours nightly

    4 months

Other Outcomes (1)

  • Change in Weight Measurement

    4 months

Study Arms (1)

Health coaching ARM

EXPERIMENTAL

Participants in this ARM will undergo health coaching for 4 months.

Behavioral: Health coaching

Interventions

Health coachingBEHAVIORAL

Health coaching

Health coaching ARM

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be eligible if they are African American (AA) men:
  • years of age at initial enrollment in the study
  • Overweight (BMI 25 - 29.99)
  • Obese (BMI 30 - 44.99)
  • Sufficiently inactive (i.e. self-report accumulating \<90 minutes/week of moderate or vigorous physical activity)
  • Categorized as low or moderate risk in accordance with American College of Sports Medicine (ACSM) guidelines for pre-exercise screening

You may not qualify if:

  • Younger than 45 years
  • Not able to speak or read English
  • Life expectancy of less than 1 year
  • Categorization of high risk in accordance with ACSM guidelines
  • Identified by one's primary care clinician as unable to follow instructions because of physical or cognitive disability
  • Psychiatric illness
  • Other unidentified reasons as determined by the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

October 3, 2018

Study Start

April 1, 2019

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)