Skip to content

Latest commit

 

History

History
207 lines (142 loc) · 7.08 KB

File metadata and controls

207 lines (142 loc) · 7.08 KB

HBTI Pilot Study Protocol

Working Title

Development of an Exploratory Metabolic Typing Instrument Integrating Self-Report and Basic Biomarker Proxies

Document Status

Draft for pilot-study preparation and manuscript scaffolding. This document does not imply validated clinical utility.

1. Background

Consumer-facing health quizzes often rely on poorly supported body-type narratives. HBTI is proposed as an alternative exploratory framework that organizes users by metabolic and behavior-related tendencies rather than visible body-shape archetypes. The framework is intended for hypothesis generation and health-management personalization research, not diagnosis.

2. Objective

To evaluate whether a four-dimension HBTI prototype can produce internally coherent participant profiles and show plausible associations with selected anthropometric, lifestyle, and basic metabolic indicators.

3. Primary Hypotheses

  1. Participants with stronger S tendencies will show less favorable carbohydrate-related proxy patterns, such as higher fasting glucose, higher triglycerides, or larger waist circumference.
  2. Participants with stronger C tendencies will report higher emotional or reward-driven eating behavior.
  3. Participants with stronger W tendencies will report shorter sleep duration, higher stress load, and less stable appetite regulation.
  4. Participants with stronger D tendencies will report lower spontaneous activity and stronger fatigue or activity suppression during caloric restriction.

4. Secondary Hypotheses

  1. The four HBTI dimensions will show acceptable internal consistency for an early exploratory instrument.
  2. Objective indicators will improve discriminative validity beyond questionnaire-only scoring.
  3. Continuous dimension scores may perform better analytically than the final 16-type code.

5. Study Design

  • Design: cross-sectional pilot study
  • Phase: exploratory instrument-development study
  • Setting: community sample or digital convenience sample
  • Data source: self-report questionnaire plus participant-provided recent health metrics

6. Target Population

Adults interested in weight management, energy regulation, or metabolic health self-tracking.

7. Inclusion Criteria

  • Age 18 years or older
  • Able to read and complete the questionnaire in the study language
  • Willing to provide self-reported lifestyle information
  • Willing to provide recent measured or lab-based health indicators if available

8. Exclusion Criteria

  • Pregnancy
  • Acute medical illness during data collection
  • Severe active eating-disorder symptoms if the study setting lacks adequate safeguards
  • Inability to provide informed consent

9. HBTI Construct Model

Dimension 1: F/S

  • F: Fuel Flexible
  • S: Sugar Sensitive
  • Intended construct: tolerance for meal spacing, carbohydrate load, and energy stability

Dimension 2: H/C

  • H: Hunger Stable
  • C: Craving Reactive
  • Intended construct: relative dominance of physiological hunger regulation versus reward- and emotion-linked intake

Dimension 3: R/W

  • R: Recovery Efficient
  • W: Stress Wired
  • Intended construct: stability of appetite, energy, and training response under sleep and stress variation

Dimension 4: N/D

  • N: Naturally Active
  • D: Energy Defending
  • Intended construct: spontaneous activity and adaptive downregulation under energy deficit

10. Measurements

A. Questionnaire Variables

  • meal spacing tolerance
  • postprandial sleepiness or energy crash
  • reward-driven eating frequency
  • emotional eating tendency
  • satiety stability after high-protein meals
  • perceived recovery from training
  • stress-related appetite dysregulation
  • spontaneous daily movement tendency
  • activity suppression during dieting

B. Anthropometric Variables

  • height
  • weight
  • body mass index
  • waist circumference

C. Routine Physiology Variables

  • resting heart rate
  • average sleep duration
  • average step count if available

D. Basic Metabolic Lab Variables

  • fasting glucose
  • HbA1c if available
  • triglycerides
  • HDL-C

11. Example Questionnaire-to-Construct Mapping

Dimension Example signal Source
F/S post-meal crash after high-carb intake self-report
F/S fasting glucose, triglycerides, waist circumference objective
H/C craving without physiological hunger self-report
R/W sleep-loss-related appetite instability self-report
R/W resting heart rate, sleep duration mixed
N/D reduced movement during calorie restriction self-report

12. Prototype Scoring Approach

Questionnaire Layer

  • Likert items scored from 1 to 5
  • Items normalized to dimension-level left/right poles
  • Higher agreement strengthens the intended pole

Objective Modifier Layer

  • Optional indicators contribute small directional weight adjustments
  • Objective indicators must not dominate the questionnaire in the pilot version
  • Missing objective values are permitted and should not block scoring

Type Output

  • Primary analytic output: continuous dimension scores
  • Secondary consumer-facing output: four-letter HBTI code

13. Statistical Analysis Plan

Instrument Development

  • Item-total correlations
  • Cronbach's alpha or McDonald's omega by dimension
  • exploratory factor analysis if sample size permits

Construct Validity

  • correlation of dimension scores with relevant biomarkers and anthropometrics
  • known-group comparisons where relevant
  • regression models controlling for age and sex if available

Output Comparison

  • compare questionnaire-only and questionnaire-plus-biomarker scoring
  • assess whether type labels lose information relative to continuous scores

14. Sample Size Guidance

For a true psychometric study, a larger sample will be needed. For an early pilot, aim for a practical initial sample sufficient to:

  • inspect item distributions
  • estimate preliminary internal consistency
  • explore directional associations

A minimal exploratory target may be 100 to 200 participants, but stronger factor-analytic work will likely require larger samples.

15. Biases and Limitations

  • self-report bias
  • convenience-sample bias
  • inconsistent recency or quality of participant lab values
  • cross-sectional design cannot establish causality
  • heuristic scoring may encode designer assumptions before empirical calibration

16. Ethics and Consent Notes

  • state clearly that HBTI is not a diagnostic tool
  • avoid collecting unnecessary health data
  • obtain explicit consent for health-related self-report fields
  • provide a support pathway if participants report disordered-eating risk signals

17. Suggested Manuscript Structure

  1. Introduction
  2. Rationale for moving beyond somatotype framing
  3. Construct development of HBTI
  4. Methods
  5. Pilot results
  6. Discussion
  7. Limitations
  8. Future validation work

18. Immediate Next Research Steps

  • refine item wording with expert review
  • pilot comprehension with a small qualitative sample
  • collect first-wave cross-sectional data
  • recalibrate item and biomarker weights using observed distributions
  • decide whether to preserve or retire the type-code layer