## Protocol Section
### Identification Module
**NCT ID:** NCT02077179

**Acronym:** HIP

**Brief Title:** Health Improvement After Pregnancy (HIP) Program Randomized Control Trial

**Official Title:** Health Improvement After Pregnancy (HIP) Program Randomized Control Trial

#### Organization Study ID Info
**ID:** OBGY-249-14
#### Organization
**Class:** OTHER
**Full Name:** Queen's University
### Status Module
#### Completion Date
**Date:** 2016-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-05

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-04

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-04

**Type:** ACTUAL

#### Start Date
**Date:** 2014-09

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2014-03-04
**Type:** ESTIMATED
**Study First Submit Date:** 2014-02-26
**Study First Submit QC Date:** 2014-03-03
**Why Stopped:** Poor retention and recruitment,changes need to be made to the program
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Queen's University

#### Responsible Party

**Investigator Affiliation:** Queen's University

**Investigator Full Name:** Dr. Graeme Smith

**Investigator Title:** Professor and Head of Obstetrics and Gynecology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and Action Plan state that women's heart health is a key national priority; it should be addressed through improving heart health awareness and prevention, and reducing care inequities for women in general and younger women in particular. The investigators have developed an innovative and interactive mobile website based postpartum lifestyle modification program (regular physical activity and nutritional guidance), based on established national guidelines, to improve heart disease risk factors in women. The investigators will conduct a trial to determine if the mobile website based lifestyle modification program can be maintained and reduces a collection of risk factors, which occurring together, greatly increases the risk of developing heart disease. The investigators hypothesize that the interactive mobile website directing regular physical activity and personalized nutritional guidance, compared to standard postpartum care, will be motivational and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the intervention group.

### Conditions Module

**Conditions:**

- Metabolic Cardiovascular Syndrome

**Keywords:**

- Postpartum

- Preeclampsia

- Gestational Hypertension

- Gestational Diabetes

- Exercise Intervention

- Dietary Intervention

- Behavioral Intervention

- Mobile Website

- Mobile Application

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 43

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider.

**Label:** Standard of Care

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Participants in this arm will follow the HIP Program in addition to their usual care from Kingston General Hospital and their primary care provider.

**Intervention Names:**

- Behavioral: HIP Program

**Label:** HIP Program

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HIP Program

**Description:** The entirety of the HIP Program is delivered through an interactive mobile website.

The physical activity portion of the program consists of daily step counting, prescribed aerobic activity, structured strength and toning workouts, and daily stretching. The program was designed by a local trainer, specializing in postnatal exercise, to increase gradually in intensity, while encouraging a more active lifestyle. The program is designed to be completed at home with minimal equipment.

The nutrition portion of the program consists of 16 video tutorials developed by a local Registered Dietitian and weekly diet logs. The video tutorials cover all aspects of healthy eating, from the basics of Canada's Food Guide, to smart snacking, to eating healthy over the holidays.

**Name:** HIP Program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome measure is the metabolic syndrome (MetS) z score, a continuous score of the five metabolic syndrome variables that make up the Adult Treatment Panel (ATP) III diagnostic criteria (waist circumference, blood pressure, high density lipoprotein, triglycerides and glucose). Differences between study arms will be compared.

**Measure:** Metabolic Syndrome Z Score

**Time Frame:** 32 weeks postpartum

#### Secondary Outcomes

**Description:** Adherence to the HIP Program will be assessed based on the number of times a participant indicates using the mobile website that a prescribed workout has been completed. This outcome will only be measured in the intervention arm.

**Measure:** Adherence to the HIP Program; Percent of Workouts Completed

**Time Frame:** 32 weeks postpartum

**Description:** Differences between study arms for the following biochemical cardiovascular risk markers will be assessed at 32 weeks postpartum; lipid profile, fasting glucose, glycated hemoglobin, high sensitivity C-reactive protein, and urine microalbumin creatinine ratio.

**Measure:** Differences in Biochemical Cardiovascular Risk Markers

**Time Frame:** 32 weeks postpartum

**Description:** Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 20 weeks postpartum. Differences between study arms will be compared.

**Measure:** Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint

**Time Frame:** 20 weeks postpartum

**Description:** Changes in systolic blood pressure, diastolic blood pressure and weight from baseline measures at 6-8 weeks postpartum will be assessed at the midpoint of the program at 32 weeks postpartum. Differences between study arms will be compared.

**Measure:** Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion

**Time Frame:** 32 weeks postpartum

**Description:** Changes in systolic blood pressure, diastolic blood pressure, weight, body mass index, hip circumference, and waist circumference from midpoint measures at 20 weeks postpartum will be assessed at the end of the program at 32 weeks postpartum. Differences between study arms will be compared.

**Measure:** Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion

**Time Frame:** 32 weeks postpartum

**Description:** Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to log their daily step count total. The number of times that the logged step count meets or exceeds the prescribed number of daily steps will also be assessed. This outcome will only be measured in the intervention arm.

**Measure:** Adherence to the HIP Program; Percent of Step Counting Completed

**Time Frame:** 32 weeks postpartum

**Description:** Adherence to the HIP Program will be assessed based on the number of times a participant uses the mobile website to enter the weekly dietary log. The number of times that the dietary log meets the prescribed intake for each of the Canada's Food Guide food groups will also be assessed. This outcome will only be measured in the intervention arm.

**Measure:** Adherence to the HIP Program; Percent of Dietary Logs Completed

**Time Frame:** 32 weeks postpartum

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- must own or have daily access to one or more of the following; smart phone, tablet or laptop computer

Exclusion Criteria:

* Living greater than 100km from Kingston General Hospital
* Having an existing and long term contraindication to exercise at the time of recruitment

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kingston

**Country:** Canada

**Facility:** Queen's Unviersity

**State:** Ontario

**Zip:** K7L 2V7

#### Overall Officials

**Official 1:**

**Affiliation:** Queen's University

**Name:** Graeme N Smith, MD,PhD,FRCSC

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Smith GN, Pudwell J, Roddy M. The Maternal Health Clinic: a new window of opportunity for early heart disease risk screening and intervention for women with pregnancy complications. J Obstet Gynaecol Can. 2013 Sep;35(9):831-839. doi: 10.1016/S1701-2163(15)30841-0. No abstract available.

**PMID:** 24099450

**Citation:** Cusimano MC, Pudwell J, Roddy M, Cho CK, Smith GN. The maternal health clinic: an initiative for cardiovascular risk identification in women with pregnancy-related complications. Am J Obstet Gynecol. 2014 May;210(5):438.e1-9. doi: 10.1016/j.ajog.2013.12.001. Epub 2013 Dec 4.

**PMID:** 24316270

**Citation:** Smith GN, Pudwell J, Walker M, Wen SW. Risk estimation of metabolic syndrome at one and three years after a pregnancy complicated by preeclampsia. J Obstet Gynaecol Can. 2012 Sep;34(9):836-841. doi: 10.1016/S1701-2163(16)35382-8.

**PMID:** 22971452

**Citation:** Smith GN, Pudwell J, Walker M, Wen SW. Ten-year, thirty-year, and lifetime cardiovascular disease risk estimates following a pregnancy complicated by preeclampsia. J Obstet Gynaecol Can. 2012 Sep;34(9):830-835. doi: 10.1016/S1701-2163(16)35381-6.

**PMID:** 22971451

**Citation:** Smith GN, Walker MC, Liu A, Wen SW, Swansburg M, Ramshaw H, White RR, Roddy M, Hladunewich M; Pre-Eclampsia New Emerging Team (PE-NET). A history of preeclampsia identifies women who have underlying cardiovascular risk factors. Am J Obstet Gynecol. 2009 Jan;200(1):58.e1-8. doi: 10.1016/j.ajog.2008.06.035. Epub 2008 Aug 8.

**PMID:** 18691690

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Cardiovascular Syndrome

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: LOW

- As Found: Unknown

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: LOW

- As Found: Unknown

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: LOW

- As Found: Unknown

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000024821

- Term: Metabolic Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
