Clinical trial NCT03886207: Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths
Official title: Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Anorexia Nervosa
Keywords: Anorexia
Footbath
Ginger powder
Thermogenic substances
Thermoregulation
External applications
Anthroposophic medicine
Eating disorders
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Filderklinik, Filderstadt, Germany
First posted: 2019-03-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are age and core body temperature stratified and then randomized to one of the two groups (footbath with warm water with additional ginger powder or warm water only). Assessments are taken before and after the six-week intervention phase as well as at six-month follow-up.
Primary purpose: TREATMENT

Brief summary: A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.

Detailed description: This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.

Eligibility criteria: Inclusion Criteria:

* main diagnosis: Anorexia nervosa
* written informed consent of participants and legal guardians

Exclusion Criteria:

* other eating disorder diagnosis apart from Anorexia nervosa
* known allergic reaction to ginger

Primary outcomes:
measure: Chnge in Subjective feeling of overall warmth
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention)
Secondary outcomes:
measure: Core body temperature
timeFrame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up
measure: Face surface temperature
timeFrame: Baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: Feet surface temperature
timeFrame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: Hand surface temperature
timeFrame: Baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: Abdomen surface temperature
timeFrame: Baseline (pre intervention) and after 6 weeks (post intervention)
measure: 24-hour feet surface temperature
timeFrame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)
measure: 24-hour hand surface temperature
timeFrame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
measure: 24-hour abdomen surface temperature
timeFrame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
measure: 24-hour torso surface temperature
timeFrame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
measure: Body Mass Index
timeFrame: Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up
measure: Pulse Transit Time (PTT)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: Perfusion Index (PI)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: Peak to Peak Time (PPT)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: SlopeInW1
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
measure: SlopeInW2
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: SlopeInW3
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: SlopeInW4
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: Stiffness Index
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: Reflection Index
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: TimeTX
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: TimeTY
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: QuotTYTX
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: AreaAX
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: AreaAY
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: QuotAYAX
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: AreaAV
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: AreaAW
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: QuotAWAV
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: QuotTVTW
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: TimeTV
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: TimeTW
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: MinT1
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: MinT2
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: MaxT1
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: MaxT2
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: QuotHRRespRate
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: Heart rate
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: Respiratory rate
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: SDNN (standard deviation of normal to normal)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: RMSSD (Root mean square of successive differences)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: pNN50
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: HF (high frequency)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
measure: LF (low frequency)
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: LF/HF-Ratio
timeFrame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
measure: Pittsburgh sleep quality index
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Eating Disorder Inventory -2
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Eating Disorder Examination- Questionnaire
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Becks Depressions Inventar
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Hospital Anxiety and Depression Scale subscale Anxiety
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Hospital Anxiety and Depression Scale subscale Depression
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Body Image State Scale
timeFrame: Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up
measure: Positive And Negative Affect Schedule
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Short Form Health Survey 12
timeFrame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
measure: Basler Befindlichkeits Skala
timeFrame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up
measure: Body Shape Questionnaire
timeFrame: Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: ARCIM Institute
state: Baden Württemberg
Study officials:
affiliation: ARCIM Institute
name: Jan Vagedes, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: