Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

NCT03700710 | Completed

• 1 other identifier: 2018-0433
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 2

Brief Summary

American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes. In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.

Conditions

Blood Pressure; High Blood Pressure; Dietary Modification; Overweight and Obesity

Keywords

lifestyle modification; DASH diet; weight loss; exercise

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour Systolic Blood Pressure

  Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

  Baseline to 12-week follow-up

Secondary Outcomes (9)

• Change in 24-hour diastolic blood pressure

  Baseline to 12-week follow-up

• Change in Daytime Systolic Blood Pressure

  Baseline to 12-week follow-up

• Change in Nighttime Systolic Blood Pressure

  Baseline to 12-week follow-up

• Change in Daytime Diastolic Blood Pressure

  Baseline to 12-week follow-up

• Change in Nighttime Diastolic Blood Pressure

  Baseline to 12-week follow-up

Other Outcomes (2)

• Change in individual components of Healthy Eating Index score

  Baseline to 12-week follow-up

• Satisfaction with the Healthy BP Research Study

  12-week follow-up

Study Arms (2)

Self-Guided Approach

ACTIVE COMPARATOR

In the self-guided arm, participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure. The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry.

Behavioral: Self-Guided Approach

Dietitian-led Approach

EXPERIMENTAL

In the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants. The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry. The web platform will be used to share participant dietary and weight data with dietitians.

Behavioral: Dietitian-led Approach

Interventions

Self-Guided Approach BEHAVIORAL

For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information. From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform. In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.

Self-Guided Approach

Dietitian-led Approach BEHAVIORAL

For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information. From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform. In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform. Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis.

Dietitian-led Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hour ambulatory SBP 120-160 mmHg
• BMI ≥ 25 kg/m2
• Access to a telephone
• Access to a computer or smartphone with internet access
• Complete dietary data entry for at least 5 out of 7 days during run-in period
• Enter weight into the platform during run-in period

You may not qualify if:

• Inability to understand English
• Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months.
• Current treatment for malignancy
• Planned or previous bariatric surgery
• Pregnant, breast-feeding, or planned pregnancy prior to the end of participation
• Self-reported average consumption of \> 21 alcoholic beverages per week or binge drinking.
• Psychiatric hospitalization in past year
• Current symptoms of angina
• Planning to leave the area prior to end of the study
• Current participation in another clinical trial
• Principal investigator discretion (i.e. concerns about safety, compliance)

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (2)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (2)

• Chang AR, Gummo L, Yule C, Bonaparte H, Collins C, Naylor A, Appel LJ, Juraschek SP, Bailey-Davis L. Effects of a Dietitian-Led, Telehealth Lifestyle Intervention on Blood Pressure: Results of a Randomized, Controlled Trial. J Am Heart Assoc. 2022 Oct 4;11(19):e027213. doi: 10.1161/JAHA.122.027213. Epub 2022 Sep 29.

  PMID: 36172955 DERIVED

• Taher M, Yule C, Bonaparte H, Kwiecien S, Collins C, Naylor A, Juraschek SP, Bailey-Davis L, Chang AR. Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial. BMJ Open. 2021 Mar 3;11(3):e044292. doi: 10.1136/bmjopen-2020-044292.

  PMID: 33658261 DERIVED

MeSH Terms

Conditions

Hypertension; Overweight; Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Alexander Chang, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: January 16, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
• Access Criteria: The deidentified IPD will be publicly available without restrictions.

Locations

US (2)