Healthy Eating and Active Living Taught at Home

NCT01567033 | Completed DMC

• 1 other identifier: 201103147
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate two different Parents as Teachers curriculums taught by parent educators, during home visits. The control curriculum includes only the standard PAT lessons; the intervention curriculum includes the standard PAT lessons plus additional information about how families can live healthy and active lives while reaching a healthy weight. The investigators hypothesize the intervention lessons will change the way people eat and/or their activity level.

Conditions

Diabetes; Obesity

Keywords

Diabetes; Obesity; Home visiting

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  Body mass index (BMI) will be used to classify participants as "obese". The investigators will calculate the BMI from weight and height measurements. Participants weight measurement will be obtained using a calibrated scale placed on a solid flat surface. The screener will record the weight in pounds. Height measurement will be the maximum vertical height measured using a stadiometer on a solid flat surface with a fixed vertical backboard and an adjustable headpiece or an approved portable stadiometer on a solid flat surface with an adjustable headpiece.

  Change in BMI from baseline to 24 months

Secondary Outcomes (3)

• Waist Circumference

  Change in waist circumference from baseline to 24 months

• Blood Pressure

  Change in blood pressure from baseline to 24 months

• Survey

  Changes in surveys from baseline to 24 months

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention participants received HEALTH, which embedded a lifestyle intervention derived from DPP within the standard PAT curriculum

Behavioral: PAT Curriculum + Health Information

Interventions

PAT Curriculum + Health Information BEHAVIORAL

Participants in the intervention group will receive the standard PAT curriculum plus information about healthy eating and an active lifestyle. This curriculum will be taught during up to 36 home visits in two years. Months 1-3 the visits are weekly; months 4-6 visits are biweekly; months 7-24 visits are monthly

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female, obese (BMI 30 -45 kg/m2),have at least one overweight or obese preschool child (\>60th percentile) living in the home, plan to continue in the PAT program for two years, and able to give informed consent to participate in HEALTH.

You may not qualify if:

• current pregnancy or plan to become pregnant in the next 24 months, inability to speak English, current enrollment in any weight loss program, a diagnosis and/or undergoing treatment for diabetes, cardiovascular disease, or eating disorders, or inability to exercise or engage in a walking program.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63112, United States

Location

Related Publications (2)

• Tabak RG, Morshed AB, Schwarz CD, Haire-Joshu D. Impact of a Healthy Weight Intervention Embedded Within a National Home Visiting Program on the Home Food Environment. Front Public Health. 2018 Jun 26;6:178. doi: 10.3389/fpubh.2018.00178. eCollection 2018.

  PMID: 29998092 DERIVED

• Haire-Joshu D, Schwarz CD, Steger-May K, Lapka C, Schechtman K, Brownson RC, Tabak RG. A Randomized Trial of Weight Change in a National Home Visiting Program. Am J Prev Med. 2018 Mar;54(3):341-351. doi: 10.1016/j.amepre.2017.12.012.

  PMID: 29455756 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra Haire Joshu, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 30, 2012
• Study Start: April 26, 2012
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

US (1)